A Phase 3 Study of Tanezumab for Chronic Low Back Pain (TANGO)
February 6, 2020 updated by: Pfizer
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks).
The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain.
Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain.
In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain.
Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group).
Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16.
At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56.
The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks).
The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.
Study Type
Interventional
Enrollment (Actual)
1832
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
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Quebec, Canada, G1V 3M7
- G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
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Ontario
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Newmarket, Ontario, Canada, L3Y 5G8
- SKDS Research Inc.
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Sarnia, Ontario, Canada, N7T 4X3
- London Road Diagnostic Clinic & Medical Centre
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Quebec
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Sherbrooke, Quebec, Canada, J1L 0H8
- Diex Research Sherbrooke Inc.
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Hillerod, Denmark, 3400
- A2 reumatologi og idraesmedicin ApS
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Paris Cedex 14, France, 75679
- Hopital Cochin
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Bekescsaba, Hungary, 5600
- Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz
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Budapest, Hungary, 1033
- Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
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Budapest, Hungary, 1036
- Obudai Egeszsegugyi Centrum Ktf.
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Kecskemét, Hungary, 6000
- Jutrix Kft.
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Miskolc, Hungary, 3529
- CRU Hungary Ltd., MISEK HOSPITAL
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Miskolc, Hungary, 3529
- CRU Hungary Ltd., MISEK-Radiology Department
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Szekszard, Hungary, 7100
- Clinfan Kft.
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Szekszard, Hungary, 7100
- Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
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Fukuoka, Japan, 813-8501
- Chihaya Hospital
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Fukuoka, Japan, 814-0165
- Kuroda Orthopedic Hospital
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Saitama, Japan, 336-8522
- Saitama Municipal Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Aichi
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Nagakute, Aichi, Japan, 480-1195
- Aichi Medical University Hospital
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Showa-ku, Nagoya, Aichi, Japan, 466-8560
- Nagoya University Hospital
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Chiba
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Chuo-ku, Chiba, Chiba, Japan, 260-8677
- Chiba University Hospital
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Funabashi, Chiba, Japan, 273-8588
- Funabashi Municipal Medical Center
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Ichihara, Chiba, Japan, 290-0003
- Chiba Rosai Hospital
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Wakaba-ku, Chiba, Chiba, Japan, 264-0017
- Chiba Central Medical Center
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Fukuoka
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Higashi-ku,Fukuoka, Fukuoka, Japan, 813-0017
- Fukuoka Mirai Hospital
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Kokuraminami-ku,Kitakyushu, Fukuoka, Japan, 800-0296
- Kyushu Rosai Hospital
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Okawa, Fukuoka, Japan, 831-0016
- Takagi Hospital
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Fukushima
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Aizuwakamatsu, Fukushima, Japan, 969-3492
- Fukushima Medical University Aizu Medical Center
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Hokkaido
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Hakodate, Hokkaido, Japan, 040-8585
- Hakodate Central General Hospital
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Hakodate, Hokkaido, Japan, 041-0802
- Hakodate Ohmura Orthopedic Hospital
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Hyogo
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Higashinada-ku, Kobe, Hyogo, Japan, 658-0011
- Kobe Konan Yamate Clinic
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Himeji, Hyogo, Japan, 670-0976
- Omuro Orthopedic Clinic
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Kako-gun, Hyogo, Japan, 675-1115
- Medical corporate corporation hoshikai Onishi medical clinic
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Kobe, Hyogo, Japan, 651-0073
- Kobe Red Cross Hospital
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Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8650
- National Hospital Organization Kanazawa Medical Center
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Komatsu, Ishikawa, Japan, 923-8507
- Morita Hospital
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Nagano
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Matsumoto, Nagano, Japan, 390-8601
- Marunouchi Hospital
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Oita
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Beppu, Oita, Japan, 874-0011
- National Hospital Organization Beppu Medical Center
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Osaka
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Higashiosaka, Osaka, Japan, 577-0011
- Sobajima Clinic
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Izumisano, Osaka, Japan, 598-8577
- Rinku General Medical Center
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Suminoe-ku, Osaka, Osaka, Japan, 559-0012
- Minamiosaka Hospital
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Saitama
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Kumagaya, Saitama, Japan, 360-0816
- Saitama Jikei Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University School of Medicine, University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8519
- Tokyo Medical And Dental University Medical Hospital
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Fussa, Tokyo, Japan, 197-8511
- Fussa Hospital
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Minato-ku, Tokyo, Japan, 108-0073
- Tokyo Saiseikai Central Hospital
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Shinagawa-ku, Tokyo, Japan, 140-0014
- Ohimachi Orthopaedic Clinic
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Shinagawa-ku, Tokyo, Japan, 140-0001
- Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University Hospital
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Yamagata
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Yonezawa, Yamagata, Japan, 992-8502
- Yonezawa City Hospital
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Yamaguchi
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Shimonoseki-shi, Yamaguchi, Japan, 750-8520
- Shimonoseki City Hospital
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Ube, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06351
- Clinical Trial Pharmacy, Samsung Medical Center
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Seoul, Korea, Republic of, 03080
- CTC Pharmacy, Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- CTC Pharmacy, Severance Hospital
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A Coruna, Spain, 15006
- Complejo hospitalario universitario a Coruña
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A Coruna, Spain, 15006
- Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia
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Alicante, Spain, 03004
- Instituto de Ciencias Médicas
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Barcelona, Spain, 08034
- Hospital Sanitas Cima
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Barcelona, Spain, 08003
- Hospital de Mar Servicio de Radiologia
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Barcelona, Spain, 08003
- Hospital del Mar Servicio de Farmacia
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Barcelona, Spain, 08006
- Specialist, S.L.
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Barcelona, Spain, 08006
- Specialist. Farmacia
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Barcelona, Spain, 08024
- Hospital del Mar
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Barcelona, Spain, 08025
- Hospital Universitario Quiron-Dexeus
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Barcelona, Spain, 08028
- Hospital Universitario Quiron-Dexeus. Servicio de Farmacia
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28050
- Hospital La Moraleja
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Madrid, Spain, 28046
- Hospital Universitario La Paz.
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Madrid, Spain, 28050
- Hospital La Moraleja. Pharmacy Service
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Malaga, Spain, 29009
- Hospital regional Universitario de Malaga
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Malaga, Spain, 29009
- Hospital Regional Universitario del Malaga
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A Coruna
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Santiago de Compostela, A Coruna, Spain, 15705
- Hospital Nuestra Señora de La Esperanza
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Gothenburg, Sweden, 413 45
- CTC (Clinical Trial Center) Sahlgrenska University Hospital
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Helsingborg, Sweden, 252 20
- PharmaSite
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Malmo, Sweden, 21152
- PharmaSite
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Stockholm, Sweden, 111 37
- ProbarE i Stockholm AB
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Alabama
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Birmingham, Alabama, United States, 35209
- Central Alabama Research
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Birmingham, Alabama, United States, 35242
- Cahaba Research
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Mobile, Alabama, United States, 36608
- Coastal Clinical Research
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Mobile, Alabama, United States, 36608
- Alabama Clinical Research, LLC
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Mobile, Alabama, United States, 36608
- Alabama Orthopaedic Clinic, P.C.
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Mobile, Alabama, United States, 36608
- Horizon Research Partners, LLC
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Saraland, Alabama, United States, 36571
- The Center for Clinical Trials, Inc.
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Arizona
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Mesa, Arizona, United States, 85215
- Ferguson Family Medicine
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Phoenix, Arizona, United States, 85018
- The Pain Center of Arizona
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Phoenix, Arizona, United States, 85053
- Arizona Research Center
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Scottsdale, Arizona, United States, 85254
- Valley Pain Consultants
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Lynn Institute of the Ozarks
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Little Rock, Arkansas, United States, 72205
- KLR Business Group dba Arkansas Clinical Research
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Little Rock, Arkansas, United States, 72205
- Primary Care of Arkansas, P.A.
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials, LLC
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Cerritos, California, United States, 90703
- Core Healthcare Group
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Chula Vista, California, United States, 91911
- eStudySite
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El Cajon, California, United States, 92020
- TriWest Research Associates, LLC
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Fresno, California, United States, 93710
- Neuro-Pain Medical Center
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Fresno, California, United States, 93702
- Research Center of Fresno, Inc.
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Fresno, California, United States, 93720
- Valley Research-Trials
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Network, LLC.
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La Mesa, California, United States, 91942
- eStudySite
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Long Beach, California, United States, 90806
- Collaborative Neuroscience Network, LLC.
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Los Angeles, California, United States, 90033
- University of Southern California
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Los Angeles, California, United States, 90033
- USC IDS Pharmacy
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Montclair, California, United States, 91763
- Catalina Research Institute, LLC
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North Hollywood, California, United States, 91606
- Providence Clinical Research
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Sacramento, California, United States, 95821
- Northern California Research
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San Diego, California, United States, 92103
- Artemis Institute for Clinical Research
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Spring Valley, California, United States, 91978
- Encompass Clinical Research
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Valley Village, California, United States, 91607
- Bayview Research Group
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
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Wildomar, California, United States, 92595
- Elite Clinical Trials, Inc.
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Colorado
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Boulder, Colorado, United States, 80301
- Alpine Clinical Research Center
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Denver, Colorado, United States, 80209
- Mountain View Clinical Research, Inc.
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Denver, Colorado, United States, 80209
- Mountain View Clinical Research, Inc
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- New England Research Associates, LLC
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Milford, Connecticut, United States, 06460
- My Health 1st Urgent Care
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Stamford, Connecticut, United States, 06905
- Stamford Therapeutics Consortium
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Florida
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Atlantis, Florida, United States, 33462
- JEM Research Institute
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Boynton Beach, Florida, United States, 33472
- Orthopedic Research Institute
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Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida
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DeLand, Florida, United States, 32720
- Midland Florida Clinical Research Center, LLC
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DeLand, Florida, United States, 32720
- Avail Clinical Research,LLC
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Fort Lauderdale, Florida, United States, 33306
- S&W Clinical Research
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Hallandale Beach, Florida, United States, 33009
- MD Clinical
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Hollywood, Florida, United States, 33024
- Pines Clinical Research Inc.
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Jacksonville, Florida, United States, 32256
- Clinical Neuroscience Solutions, Inc.
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Jupiter, Florida, United States, 33458
- Health Awareness, Inc.
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Miami, Florida, United States, 33125
- Columbus Clinical Services, LLC
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Miami, Florida, United States, 33185
- M & M Medical Center, Inc
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Miami, Florida, United States, 33186
- Quality Research & Medical Center LLC
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Miami, Florida, United States, 33173
- Larkin Imaging Center
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Miami Lakes, Florida, United States, 33014
- Crystal Biomedical Research, LLC
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Ocoee, Florida, United States, 34761
- Sensible Healthcare, LLC.
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Orlando, Florida, United States, 32806
- Compass Research, LLC
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Orlando, Florida, United States, 32807
- National Pain Research Institute
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, United States, 33709
- Meridien Research
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Sarasota, Florida, United States, 34232
- Gulfcoast Research Institute
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Tampa, Florida, United States, 33634
- Meridien Research
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West Palm Beach, Florida, United States, 33409
- Palm Beach Research Center
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Georgia
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Blue Ridge, Georgia, United States, 30513
- River Birch Research Alliance, Llc
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Columbus, Georgia, United States, 31904
- Columbus Regional Research Institute
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Gainesville, Georgia, United States, 30501
- Center for Advanced Research & Education
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Marietta, Georgia, United States, 30060
- Georgia Institute for Clinical Research, LLC
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Marietta, Georgia, United States, 30060
- Drug Studies America
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Marietta, Georgia, United States, 30060
- Non-Surgical Orthopaedics, P.C.
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Newnan, Georgia, United States, 30265
- Better Health Clinical Research, Inc.
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Newnan, Georgia, United States, 30265
- Better Health Clinical Research Inc
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Savannah, Georgia, United States, 31401
- Southeast Regional Research Group
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Woodstock, Georgia, United States, 30189
- North Georgia Clinical Research
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Woodstock, Georgia, United States, 30189
- North Georgia Internal Medicine
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Hawaii
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Honolulu, Hawaii, United States, 96814
- East-West Medical Research Institute
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, United States, 60640
- Great Lakes Clinical Trials
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Chicago, Illinois, United States, 60657
- Chicago Anesthesia Pain Specialists
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Chicago, Illinois, United States, 60607
- Chicago Clinical Research Institute, Inc.
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Chicago, Illinois, United States, 60602
- Medex Healthcare Research Inc
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center
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Chicago, Illinois, United States, 60611
- Northwestern University, Feinberg School of Medicine, Lavin Pavilion
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Skokie, Illinois, United States, 60076
- Clinical Investigation Specialists, Inc.
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Indiana
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Brownsburg, Indiana, United States, 46112
- Investigators Research Group, LLC
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Evansville, Indiana, United States, 47714
- MediSphere Medical Research Center, LLC
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Lafayette, Indiana, United States, 47905
- Lafayette Clinical Research Group
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Lafayette, Indiana, United States, 47905
- Lafayette Regional Vein and Laser Center
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Valparaiso, Indiana, United States, 46383
- Buynak Clinical Research, P.C.
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Iowa
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Des Moines, Iowa, United States, 50309
- The Iowa Clinic
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Des Moines, Iowa, United States, 50309
- The Iowa Clinic - Internal Medicine
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Des Moines, Iowa, United States, 50309
- The Iowa Clinic Medical Imaging
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West Des Moines, Iowa, United States, 50266
- The Iowa Clinic
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West Des Moines, Iowa, United States, 50266
- The Iowa Clinic Medical Imaging
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Kansas
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Overland Park, Kansas, United States, 66210
- Mid-America Physiatrists, P.A.
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Wichita, Kansas, United States, 67205
- Professional Research Network of Kansas, LLC
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Kentucky
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Crestview Hills, Kentucky, United States, 41017
- Mayfield Imaging Center
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Edgewood, Kentucky, United States, 41017
- Otri-Med Corporation
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Edgewood, Kentucky, United States, 41017
- St Elizabeth Hospital Edgewood
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Louisiana
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Bossier City, Louisiana, United States, 71111
- Willis-Knighton Physician Network/ Spine and Pain Specialist
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Bossier City, Louisiana, United States, 71111
- Willis-Knighton Physician Network/WKB Family Medicine Associates
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Lake Charles, Louisiana, United States, 70601
- Centex Studies, Inc
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New Orleans, Louisiana, United States, 70115
- Best Clinical Trials, LLC
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New Orleans, Louisiana, United States, 70115
- George Stanley Walker, MD
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Maryland
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Cumberland, Maryland, United States, 21502
- Klein & Associates, M.D., P.A.
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Wheaton, Maryland, United States, 20902
- The Center for Rheumatology and Bone Research
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Chestnut Hill, Massachusetts, United States, 02467
- Brigham and Women's Hospital
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Quincy, Massachusetts, United States, 02169
- Beacon Clinical Research, LLC
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Watertown, Massachusetts, United States, 02472
- MedVadis Research Corporation
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Michigan
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Bay City, Michigan, United States, 48706
- Great Lakes Research Group, Inc.
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Rochester Hills, Michigan, United States, 48307
- Michigan Orthopaedic Spine Surgeons
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Troy, Michigan, United States, 48085
- Oakland Medical Research
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Wyoming, Michigan, United States, 49519
- Michigan Pain Consultants
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Mississippi
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Jackson, Mississippi, United States, 39202
- CRC of Jackson, LLC
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Jackson, Mississippi, United States, 39202
- Physician's Surgery Center
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Olive Branch, Mississippi, United States, 38654
- Olive Branch Family Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63117
- Medex Healthcare Research, Inc.
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Nebraska
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Omaha, Nebraska, United States, 68134
- Heartland Clinical Research, Inc.
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Nevada
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Las Vegas, Nevada, United States, 89123
- Advanced Biomedical Research of America
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Las Vegas, Nevada, United States, 89106
- Affiliated Clinical Research, Inc.
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Las Vegas, Nevada, United States, 89117
- Office of Stephen H. Miller, MD
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Las Vegas, Nevada, United States, 89119
- Office of Robert Kaplan, DO
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- ActivMed Practices & Research, Inc.
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New Jersey
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Berlin, New Jersey, United States, 08009
- Comprehensive Clinical Research
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Marlton, New Jersey, United States, 08053
- CRI Worldwide, LLC
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Somerset, New Jersey, United States, 08873
- University Clinical Research Center
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Trenton, New Jersey, United States, 08611
- Premier Research
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Albuquerque Clinical Trials, Inc.
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Albuquerque, New Mexico, United States, 87106
- New Mexico Clinical Research & Osteoporosis Center, Inc.
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New York
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Brooklyn, New York, United States, 11206
- Healthwise Medical Associates
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Hartsdale, New York, United States, 10530
- Drug Trials America
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New York, New York, United States, 10128
- The Medical Research Network, LLC
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Rochester, New York, United States, 14618
- AAIR Research Center
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Rochester, New York, United States, 14618
- University of Rochester
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North Carolina
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Lenoir, North Carolina, United States, 28645
- Northstate Clinical Research
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Mooresville, North Carolina, United States, 28117
- On Site Clinical Solutions, LLC
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates, LLC
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Winston-Salem, North Carolina, United States, 27103
- PMG Research of Winston-Salem, LLC
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research
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North Dakota
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Fargo, North Dakota, United States, 58104
- Plains Clinical Research Center, LLC
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Fargo, North Dakota, United States, 58104
- Lillestol Research, LLC
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Frgi, North Dakota, United States, 58104
- Heartland Diagnostics
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Ohio
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Beavercreek, Ohio, United States, 45431
- Clinical Inquest Center Ltd
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Centerville, Ohio, United States, 45459
- Valley Medical Research/Valley Medical Primary Care
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Cincinnati, Ohio, United States, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, United States, 45224
- Hightop Medical Research Center
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Columbus, Ohio, United States, 43235
- Optimed Research Ltd
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Franklin, Ohio, United States, 45005
- Prestige Clinical Research
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Mentor, Ohio, United States, 44060
- Great Lakes Medical Research, LLC
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Mentor, Ohio, United States, 44060
- Oaktree Clinic
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Toledo, Ohio, United States, 43623
- Bone Joint & Spine Surgeons, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Lynn Health Science Institute
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Oklahoma City, Oklahoma, United States, 73103
- Health Research of Oklahoma
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Oklahoma City, Oklahoma, United States, 73109
- NPC Research
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Oklahoma City, Oklahoma, United States, 73103
- COR Clinical Research, L.L.C
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Pennsylvania
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Downingtown, Pennsylvania, United States, 19335
- Brandywine Clinical Research
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Omega Medical Research
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South Carolina
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Columbia, South Carolina, United States, 29204
- TLM Medical Services
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Greer, South Carolina, United States, 29650
- DeGarmo Institute of Medical Research
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North Charleston, South Carolina, United States, 29406
- Lowcountry Orthopaedics & Sports Medicine
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Health Concepts
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Tennessee
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Knoxville, Tennessee, United States, 37909
- PCET Research Center, LLC
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Nashville, Tennessee, United States, 37211
- Quality Medical Research
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Texas
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Arlington, Texas, United States, 76012
- KRK Medical Research
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Houston, Texas, United States, 77074
- Clinical Trial Network
-
Houston, Texas, United States, 77030
- Advances In Health
-
Houston, Texas, United States, 77058
- Centex Studies, Inc./Clear Lake Family Physicians
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Plano, Texas, United States, 75024
- The Pain Relief Center
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San Antonio, Texas, United States, 78213
- Lee Medical Associates, PA
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San Antonio, Texas, United States, 78213
- Progressive Clinical Research, PA
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San Antonio, Texas, United States, 78209
- Quality Research, Inc.
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Utah
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Draper, Utah, United States, 84020
- Physicians Research Options, LLC
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Virginia
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Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research Center, LLC
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Midlothian, Virginia, United States, 23114
- Virginia Research Center
-
Richmond, Virginia, United States, 23294
- National Clinical Research - Richmond, Inc.
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
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Bellevue, Washington, United States, 98004
- Washington Center for Pain Management
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Exclusion Criteria:
--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
- Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;
- History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
- History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
- Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
- History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo to Week 16; tanezumab 5 mg SC
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Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
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Placebo Comparator: Placebo to Week 16, tanezumab 10 mg SC
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Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
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Experimental: Tanezumab 5 mg SC
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Tanezumab 5 mg SC
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Experimental: Tanezumab 10 mg SC
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Tanezumab 10 mg SC
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Active Comparator: Tramadol PR oral
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Tramadol PR oral
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16
Time Frame: Baseline, Week 16
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Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT).
Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
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Baseline, Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Withdrew Due to Lack of Efficacy
Time Frame: Baseline up to Week 56
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Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
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Baseline up to Week 56
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Time to Discontinuation Due to Lack of Efficacy
Time Frame: Baseline up to Week 56
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Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
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Baseline up to Week 56
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Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo
Time Frame: Baseline, Week 16
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The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities.
It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP.
The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
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Baseline, Week 16
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Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16
Time Frame: Baseline, Week 16
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Average LBP was assessed on an 11-point NRS captured through an IRT.
Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
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Baseline, Week 16
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Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
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Average LBP was assessed on an 11-point NRS captured through an IRT.
The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64.
Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
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Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
Time Frame: Baseline, Week 64
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Average LBP was assessed on an 11-point NRS captured through an IRT.
The LBPI score was captured once a week for week 64.
Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
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Baseline, Week 64
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Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities.
It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP.
The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
Time Frame: Baseline, Weeks 64 and 80
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The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities.
It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP.
The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
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Baseline, Weeks 64 and 80
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Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?"
Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Higher scores indicated worsening of condition.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data
Time Frame: Baseline, Week 64
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PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?"
Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Higher scores indicated worsening of condition.
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Baseline, Week 64
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Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Time Frame: Baseline, Weeks 16, 24 and 56
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Average LBP was assessed on an 11-point NRS captured through an IRT.
LBPI score was captured once a week for week 64.
Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was imputed using mixed BOCF/LOCF.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
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Baseline, Weeks 16, 24 and 56
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Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
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Average LBP was assessed on an 11-point NRS captured through an IRT.
The LBPI score was captured once a week for week 64.
Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Percentage of participants with reduction in LBPI of at least (>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 compared to baseline were classified as responders to LBPI and are reported here, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
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Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
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Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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RMDQ: health status measure index of how well participants with LBP are able to function with regard to daily activities.
Measures pain and function using 24 items describing limitations to everyday life.
Total score of RMDQ is total number of items checked ranging from 0=no disability to 24=maximum disability, higher scores=greater disability.
Percentage of participants with reduction in LBPI of at least (>=) 30, 50, 70 and 90% at specified weeks compared to baseline were classified as responders to LBPI and are reported here.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
Time Frame: Baseline, Weeks 16, 24 and 56
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The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities.
It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP.
The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.
Percentage of participants with cumulative reduction (as percent) (>0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 %, 90% and =100 %) in RMDQ from Baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 16, 24 and 56
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Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'.
For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity.
Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data
Time Frame: Baseline, Week 64
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'.
For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity.
Question 5 (7-items) assessed level of pain interference on daily activities.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'.
For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity.
Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data
Time Frame: Baseline, Week 64
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'.
For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity.
Question 5 (7-items) assessed level of pain interference on daily activities.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data
Time Frame: Baseline, Week 64
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data
Time Frame: Baseline, Week 64
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data
Time Frame: Baseline, Week 64
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data
Time Frame: Baseline, Week 64
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
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Baseline, Week 64
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data
Time Frame: Baseline, Week 64
|
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation.
Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities.
Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life.
Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.
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Baseline, Week 64
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Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Chronic Low Back Pain Responder Index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of Low Back Pain, and RMDQ total score.
Participants were successful responders if they had: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in PGA of low back pain from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
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Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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PGA of LBP assessed by asking question to participants:Considering all ways your low back pain affects you,how are you doing today?
They responded on 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic & no limitation of normal activities);2=good (mild symptoms and no limitation of normal activities);3=fair (moderate symptoms and limitation of some normal activities);4=poor (severe symptoms & inability to carry out most normal activities); & 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Higher scores indicated worsening of condition.
% of participants with improvement of at least 2 points from baseline in PGA of LBP were reported.
Missing data was imputed using BOCF/LOCF.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
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European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
Time Frame: Baseline, Weeks 8, 16, 24, 40 and 56
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EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.
EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS).
EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Individual dimension scores ranged from 1.0 (least impairment of health state) to 5.0 (most impairment of health state).
Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.
The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
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Baseline, Weeks 8, 16, 24, 40 and 56
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European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
Time Frame: Baseline, Weeks 8, 16, 24, 40, 56 and 64
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EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.EQ-5D-5L consists of 2 components: a health state profile and an optional VAS.EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Individual dimension scores ranged from 1.0(least impairment of health state) to 5.0(most impairment of health state).
Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.Responses from five domains were used to calculate a single utility index (Overall health utility score) where values are less than equal to (<=) 1.Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and reduced where participant reports greater levels of problems across five dimensions.
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Baseline, Weeks 8, 16, 24, 40, 56 and 64
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Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
Time Frame: Baseline
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WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities.
It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment).
These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Pre-specified intent of study for efficacy data up to Week 16 was to analyze, participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16 in placebo arm, in pooled manner.
Hence data have been reported per four arms.
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Baseline
|
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
Time Frame: Baseline, Weeks 16, 56 and 64
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WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities.
It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment).
These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Baseline, Weeks 16, 56 and 64
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Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
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In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56.
Number of participants with any use of rescue medication during the particular study week were summarized.
As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms.
This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.
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Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
|
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Number of Participants Who Took Rescue Medication During Week 64: Observed Data
Time Frame: Week 64
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In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary.
Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.
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Week 64
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Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
|
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56.
Number of days the participants used the rescue medication during the particular study weeks were summarized.
As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms.
This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.
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Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
|
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Number of Days of Rescue Medication Used at Week 64
Time Frame: Week 64
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In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56.
Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.
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Week 64
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Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
Time Frame: Weeks 2, 4, 8, 12 and 16
|
In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56.
The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.
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Weeks 2, 4, 8, 12 and 16
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Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
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Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (for Baseline during the last 3 months for baseline, weeks 64 and 80, via IRT).
Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Participants might have been counted more than once under various categories.
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Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
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Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of participants who visited the emergency room due to low back pain.
|
Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of visits to the emergency room due to low back pain.
|
Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of participants who were hospitalized due to low back pain.
|
Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of nights stayed in the hospital due to low back pain.
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Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of participants who used any aids/devices for doing things.
Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
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Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was number of participants who quit job due to low back pain.
|
Baseline, Weeks 64 and 80
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Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
Time Frame: Baseline, Weeks 64 and 80
|
Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT.
Domain evaluated was duration since quitting job due to low back pain.
|
Baseline, Weeks 64 and 80
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|
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
Time Frame: Weeks 16 and 56
|
TSQM v.II: self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (7 questions scored on 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]), effectiveness and side effects/tolerability (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied], 1 question on 2 point scale [0 =No, 1=Yes]).
11 questions of TSQM were used to calculate 4 endpoints of effectiveness, side effects, convenience and global satisfaction, each scored on a 0-100 scale with 100=best level of satisfaction.
Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
|
Weeks 16 and 56
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|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
Time Frame: Weeks 16 and 56
|
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment.
To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment.
Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
|
Weeks 16 and 56
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|
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
Time Frame: Weeks 16 and 56
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mPRTI : self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment & preference to continue using investigational product) & participant willingness to use drug again assessment.
To assess preference to continue using investigational product, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment.
Higher scores indicate lesser preference to use investigational product.
Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
|
Weeks 16 and 56
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Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
Time Frame: Weeks 16 and 56
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mPRTI: self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) & participant willingness to use drug again assessment.
To assess participants willingness to use drug again, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again.
Higher scores indicate lesser willingness to use the investigational product.
Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.
|
Weeks 16 and 56
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 80
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug and up to week 80 that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious AEs.
|
Baseline up to Week 80
|
|
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56
Time Frame: Baseline up to Week 56
|
Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug and up to W56 that were absent before treatment or that worsened relative to pre-treatment state.
Relatedness to study drug was assessed by the investigator.
Pre-specified intent of study for summaries for the entire treatment period (up to week 56), data was summarized by 3 arms.
|
Baseline up to Week 56
|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Time Frame: Baseline up to Week 80
|
Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery.
mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN;
WBC count<0.6*LLN,
>1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN;
Prothrombin time/Intl.
normalized ratio>1.1*ULN;
total bilirubin>1.5*ULN;
aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN,
>1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN;
sodium<0.95*LLN,>1.05*ULN;
potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN,
>1.2*ULN; glucose<0.6*LLN,
>1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN,
specific gravity<1.003,
>1.030; pH<4.5, >8; Urine Glucose, protein,HGB,bilirubin >=1; Ketones>=1;Urine erythrocytes,Leukocytes>=20.
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Baseline up to Week 80
|
|
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Time Frame: Baseline up to Week 80
|
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery.
mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper
limit of normal (ULN); white blood cell count<0.6*LLN,
>1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN;
aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN,
>1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN;
potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN;
Nitrite >=1.
|
Baseline up to Week 80
|
|
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
|
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
Heart rate was measured at sitting position.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
Time Frame: Baseline, Weeks 16, 56 and 80
|
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment.
All standard intervals {RR interval, PR interval, QRS interval, QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF)} were collected.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 16, 56 and 80
|
|
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
Time Frame: Baseline, Weeks 16, 56 and 80
|
Heart rate was measured at sitting position.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 16, 56 and 80
|
|
Number of Participants With Confirmed Orthostatic Hypotension
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements.
For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements.
If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive.
If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.
|
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
|
Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Time Frame: Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80
|
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated.
Each positive symptom is rated from 1 (not at all) to 5 (a lot).
The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom.
The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80
|
|
Percentage of Participants With Adjudicated Joint Safety Outcomes
Time Frame: Baseline up to Week 80
|
Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.
|
Baseline up to Week 80
|
|
Percentage of Participants With Total Joint Replacements
Time Frame: Baseline up to Week 80
|
Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.
|
Baseline up to Week 80
|
|
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy.
NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment.
NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
|
|
Number of Participants With Anti Tanezumab Antibodies
Time Frame: Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80
|
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32.
Less than 3.32 was considered below the limit of quantitation.
Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.
|
Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Markman JD, Schnitzer TJ, Perrot S, Beydoun SR, Ohtori S, Viktrup L, Yang R, Bramson C, West CR, Verburg KM. Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial. Pain Ther. 2022 Dec;11(4):1267-1285. doi: 10.1007/s40122-022-00424-7. Epub 2022 Aug 13.
- Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2015
Primary Completion (Actual)
October 17, 2017
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
August 11, 2015
First Submitted That Met QC Criteria
August 18, 2015
First Posted (Estimate)
August 19, 2015
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4091059 (Other Identifier: Pfizer)
- 2012-005495-34 (EudraCT Number)
- CLBP SC STUDY (Other Identifier: Alias Study Number)
- TANGO (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
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University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
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Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
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Ache Laboratorios Farmaceuticos S.A.Unknown
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Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
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Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
Clinical Trials on Placebo to Week 16; tanezumab 5mg SC
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PfizerTerminatedPain | Arthritis | OsteoarthritisUnited States
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PfizerCompletedOsteoarthritis, Knee | Osteoarthritis, HipUnited States, Puerto Rico, Canada
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Boehringer IngelheimCompletedHepatitis C, ChronicUnited States, Australia, Belgium, Canada, France, Germany, Greece, Italy, New Zealand, Portugal, Spain, United Kingdom
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Chong Kun Dang PharmaceuticalCompleted
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GlaxoSmithKlineCompletedPain, InflammatoryUnited Kingdom, Germany, Poland
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GlaxoSmithKlineCompletedMuscular DystrophiesUnited States
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University Hospital, ToulouseCompletedPrader-Willi SyndromeFrance
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Hoffmann-La RocheCompletedRheumatoid ArthritisFrance, Germany, Italy, Spain, United Kingdom, Hong Kong, United States, Colombia, Brazil, Canada, New Zealand, South Africa, Philippines, Russian Federation, Thailand, Singapore, Bulgaria, Mexico, Australia, Lithuania, Poland, Ar... and more
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Medicines for Malaria VentureUniversity of Cape TownCompleted
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Suzhou Kintor Pharmaceutical Inc,CompletedTo Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic AlopeciaAlopecia | Male Pattern Hair LossUnited States