A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

July 12, 2021 updated by: Pfizer

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels

Study Overview

Detailed Description

This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

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

      • Brussel, Belgium, B-1090
        • Universitair Ziekenhuis Brussel
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, B-3000
        • Universitair Ziekenhuis Gasthuisberg
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • The Gateway 2
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male/Female Health and Research Centre, Royal Court Medical Centre
      • Kingston, Ontario, Canada, K7L 3J7
        • Centre for Applied Urological Research
      • Kingston, Ontario, Canada, K7N 2V7
        • Kingston General Hospital
      • Kitchener, Ontario, Canada, N2N 2B9
        • Urology Associates / Urologic Medical Research
      • Thunder Bay, Ontario, Canada, P7E 6E7
        • Anthony Skehan Medicine Professional Corporation
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • Kouvola, Finland, 45200
        • Kouvolan lääkäriasema
      • Shatin, Hong Kong
        • Department of Surgery, The Chinese University of Hong Kong
    • NEW Territories
      • Shatin, NEW Territories, Hong Kong
        • Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-0033
        • Harasanshin Hospital, Urology
    • Kyoto
      • Nakagyo-ku, Kyoto-shi, Kyoto, Japan, 604-8845
        • Kyoto City Hospital, Urology
    • Tokyo
      • Arakawa-ku, Tokyo, Japan, 116-8567
        • Tokyo Women's Medical University Medical Center East
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Tokyo University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
      • Seoul, Korea, Republic of, 110-744
        • Department of Urology, Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Department of Urology, Korea University Anam Hospital
    • Seoul
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • Department of Urology, Asan Medical Center, University of Ulsan
      • Bialystok, Poland, 15-950
        • SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii
      • Warszawa, Poland, 00-846
        • Conti Medica Sp. z o.o.
      • Warszawa, Poland, 01-194
        • Spoldzielnia Pracy Specjalistow Radiologow
      • Warszawa, Poland, 01-432
        • NZOZ Centrum Medyczne Wola
      • Warszawa, Poland, 02-005
        • Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen
      • Bucuresti, Romania, 050653
        • Spitalul Clinic Prof. Dr. Th. Burghele
      • Pantelimon, Romania
        • Centrul Medical Sf. Pantelimon
    • Sector 4
      • Bucuresti, Sector 4, Romania, 041345
        • Dinu Uromedica SCM
      • Moscow, Russian Federation, 105425
        • Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology
      • Moscow, Russian Federation, 105425
        • Urology of Rosmedtechnology
      • Saint-Petersburg, Russian Federation, 198205
        • Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology
      • St. Petersburg, Russian Federation, filial 1 197022
        • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava
      • St. Petersburg, Russian Federation, filial 1, 197022
        • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology
      • Martin, Slovakia, 036 59
        • Univerzitná nemocnica Martin
      • Martin, Slovakia, 036 59
        • Martinska Fakultna Nemocnica
      • Presov, Slovakia, 080 01
        • MILAB s.r.o.
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial de Barcelona
      • Barcelona, Spain, 08024
        • Clinica Del Remei - Instituto Medico Tecnologico
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Goteborg, Sweden, 413 45
        • Kliniska provningsenheten
      • Malmo, Sweden, 211 36
        • Medicinsk Rontgen (x-ray only)
      • Malmo, Sweden, 211 52
        • Center for Lakemedelsprovning Malmo
      • Koahsiung Hsien, Taiwan, 833
        • Chang Gung Medical Foundation - Kaohsiung/Department of Surgery
      • Taichung City, Taiwan, 403
        • Taichung Hospital, Department of Health, Executive Yuan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital (X-Ray Only)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital/Department of Surgery
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
      • Mobile, Alabama, United States, 36608
        • Alabama Orthopaedic Clinic
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Canyon State Urology
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Phoenix, Arizona, United States, 85020
        • Urology Specialists, Ltd.
      • Phoenix, Arizona, United States, 85021
        • Central Arizona Urologists
      • Phoenix, Arizona, United States, 85032
        • Precision Trials, LLC
      • Phoenix, Arizona, United States, 85032
        • Valley Radiologists (x-ray only)
      • Phoenix, Arizona, United States, 85032
        • Valley Urologic Associates
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale Medical Imaging
      • Tucson, Arizona, United States, 85711
        • Radiology Limited (x-ray only)
      • Tucson, Arizona, United States, 85712
        • Arizona Urologic Specialists
    • California
      • Beverly Hills, California, United States, 90211
        • Access Medical Imaging
      • Fresno, California, United States, 93720
        • Urology Associates of Central California
      • Glendora, California, United States, 91741
        • Citrus Valley Medical Research Inc.
      • Long Beach, California, United States, 90806
        • Atlantic Urology Medical Group
      • Los Angeles, California, United States, 90048
        • Institute for Advanced Urology
      • Murrieta, California, United States, 92562
        • Tri Valley Urology Group
      • Murrieta, California, United States, 92562
        • Valley Neurology
      • Signal Hill, California, United States, 90755
        • Liberty Pacific Medical Imaging
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center, PC
      • Longmont, Colorado, United States, 80501
        • Longmont Medical Research Network
      • Longmont, Colorado, United States, 80501
        • Longmont Clinic, PC
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Women's Health Specialty Care
      • New Britain, Connecticut, United States, 06052
        • Grove Hill Clinical Research
      • New Britain, Connecticut, United States, 06052
        • Urology Center of Grove Hill
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
      • Stamford, Connecticut, United States, 06902
        • Brian J. Hines, MD
    • Delaware
      • Dover, Delaware, United States, 19901
        • Diagnostic Imaging (radiology only)
      • Dover, Delaware, United States, 19904
        • Urology Associates of Dover
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Lake Worth, Florida, United States, 33461
        • University Urologists
      • Naples, Florida, United States, 34102
        • Specialists in Urology
      • New Port Richey, Florida, United States, 34652
        • Advanced Urology Associates
      • New Port Richey, Florida, United States, 34652
        • Excel Medical Imaging
      • New Port Richey, Florida, United States, 34655
        • Urology Specialists of West Florida
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Ocala, Florida, United States, 34471
        • Advanced Imaging Center Incorporated
      • Ocala, Florida, United States, 34471
        • Ocala Urology Specialists
      • Pinellas Park, Florida, United States, 33781
        • Gateway Radiology (x-rays only)
      • Saint Petersburg, Florida, United States, 33710
        • Pinellas Urology, Inc.
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute Incorporated
      • West Palm Beach, Florida, United States, 33417
        • Midtown Imaging
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Medical Research Institute, LLC
      • Alpharetta, Georgia, United States, 30005
        • Northside Hospital Radiology Services (x-ray only)
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30308
        • MRI Imaging Of Georgia
      • Atlanta, Georgia, United States, 30327
        • MRI Imaging Of Georgia
      • Decatur, Georgia, United States, 30033
        • Georgia Urology
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic Downtown Research Institute
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic Gateway Health Center Research Institute
      • Noblesville, Indiana, United States, 46062
        • American Health Network (X-Ray only)
      • Noblesville, Indiana, United States, 46062
        • Urology of Indiana, LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, Medical Imaging
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, Urology
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Diagnostics Imaging
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Urology, PA
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Alpha Clinical Research
      • Fall River, Massachusetts, United States, 02720
        • Genesis Clinical Research and Consulting
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Kalamazoo, Michigan, United States, 49008
        • HealthCare Midwest
      • Kalamazoo, Michigan, United States, 49009-2175
        • Rheumatology Pc
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospitals - Royal Oak
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology, P.C.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • CRL Imaging Southdale (x-rays only)
      • Edina, Minnesota, United States, 55435
        • Medical Advanced Pain Specialists Applied Research Center Incorporated
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Southeast Urology Network
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Family Health Care Center (X-Ray)
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, P.C.
    • New York
      • Albany, New York, United States, 12208
        • Capital Region Urological Surgeons
      • Kingston, New York, United States, 12401
        • Hudson Valley Urology, PC
      • Kingston, New York, United States, 12401
        • Benedictine Hospital
      • New York, New York, United States, 10016
        • University Urology Associates
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology, PC
      • Poughkeepsie, New York, United States, 12601
        • DRA Imaging, PC (X-Rays Only)
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester, Department of Urology
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Crescent Medical Research
      • Salisbury, North Carolina, United States, 28144
        • Salisbury Urological Clinic
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Tri-State Urologic Services PSC, Inc. dba The Urology Group
      • Cofumbus, Ohio, United States, 43221
        • Central Ohio Urology Group
      • Columbus, Ohio, United States, 43220
        • Columbus Urology Research, LLC
      • Westerville, Ohio, United States, 43081
        • Premier Urology
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Legacy Clinical Research, LLC
      • Tulsa, Oklahoma, United States, 74105
        • Planned Parenthood of Arkansas and Eastern Oklahoma
      • Tulsa, Oklahoma, United States, 74127
        • Oklahoma State University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of Southeastern Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Jeanes Hospital
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Matrix Research, LLC
      • Greer, South Carolina, United States, 29650
        • The Urology Group
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Tricities Medical Research
      • Bristol, Tennessee, United States, 37620
        • Bristol Urological Associates, PC
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center for Clinical Research
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group
      • Knoxville, Tennessee, United States, 37920
        • University Urology
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Memphis, Tennessee, United States, 38119
        • Southeast Urology Network
      • Memphis, Tennessee, United States, 38018
        • The Neurology Clinic
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials, Inc (ACT)
      • Nashville, Tennessee, United States, 37203
        • Center for Urological Treatment
      • Nashville, Tennessee, United States, 37203
        • Diagnostic Health
      • Nashville, Tennessee, United States, 37203
        • Swan and Brennan, Incorporated
      • Nashville, Tennessee, United States, 37203
        • The Center for Reproductive Health
    • Texas
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
      • Houston, Texas, United States, 77024
        • Mobley Research Center
      • Houston, Texas, United States, 77030
        • St. Luke's Diagnostic and Treatment Center Kirby Glen
      • Houston, Texas, United States, 77062
        • Centex Research, Inc.
    • Utah
      • Murray, Utah, United States, 84107
        • Rocky Mountain Neurological Associates
      • Murray, Utah, United States, 84107
        • Salt Lake Surgical Center
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research, PLLC
      • Salt Lake City, Utah, United States, 84102
        • Salt Lake Regional Medical Center (X-rays only)
      • Salt Lake City, Utah, United States, 84124
        • Western Urological Clinic, PC
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research, LLC
      • Mountlake Terrace, Washington, United States, 98043
        • Urology Northwest
      • Seattle, Washington, United States, 98133
        • Marc Kirschner, MD

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
  • Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

  • Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
  • Body mass index (BMI) of >39 kg/m2.
  • History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  • Patients with peripheral neuropathy.
  • Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
1 mg dose given subcutaneously twice at an 8-week interval.
2.5 mg dose given subcutaneously twice at an 8-week interval.
10 mg dose given subcutaneously twice at an 8-week interval.
20 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 1
1 mg dose given subcutaneously twice at an 8-week interval.
2.5 mg dose given subcutaneously twice at an 8-week interval.
10 mg dose given subcutaneously twice at an 8-week interval.
20 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 3
1 mg dose given subcutaneously twice at an 8-week interval.
2.5 mg dose given subcutaneously twice at an 8-week interval.
10 mg dose given subcutaneously twice at an 8-week interval.
20 mg dose given subcutaneously twice at an 8-week interval.
Experimental: Group 4
1 mg dose given subcutaneously twice at an 8-week interval.
2.5 mg dose given subcutaneously twice at an 8-week interval.
10 mg dose given subcutaneously twice at an 8-week interval.
20 mg dose given subcutaneously twice at an 8-week interval.
Placebo Comparator: Group 5
Placebo dose given subcutaneously twice at an 8-week interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Average Daily Pain Score at Week 8
Time Frame: Baseline, Week 8
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Time Frame: Week 8, 16
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Week 8, 16
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Patient Global Assessment of Health Status Scores
Time Frame: Baseline, Week 2, 8, 16, 24
Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.
Baseline, Week 2, 8, 16, 24
Number of Participants With Global Response Assessment Scores
Time Frame: Week 8, 16, 24
Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.
Week 8, 16, 24
Number of Micturitions Per 24 Hours
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24
The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.
Baseline, Week 4, 8, 12, 16, 20, 24
Number of Nocturnal Micturitions Per 24 Hours
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24
The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Baseline, Week 4, 8, 12, 16, 20, 24
Number of Micturition-related Urgency Episodes Per 24 Hours
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24
The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Baseline, Week 4, 8, 12, 16, 20, 24
Participant's Urge to Urinate
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24
Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.
Baseline, Week 4, 8, 12, 16, 20, 24
Mean Voided Volume Per Micturition
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24
Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.
Baseline, Week 4, 8, 12, 16, 20, 24
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Time Frame: Baseline, Week 2, 8, 16, 24
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.
Baseline, Week 2, 8, 16, 24
Brief Pain Inventory-Short Form (BPI-sf) Score
Time Frame: Baseline, Week 8, 16, 24
BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.
Baseline, Week 8, 16, 24
Number of Participants With Patient Global Satisfaction Assessment Scores
Time Frame: Week 8, 16, 24
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.
Week 8, 16, 24
Number of Participants With Patient Global Preference Assessment Score
Time Frame: Week 8, 16, 24
Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.
Week 8, 16, 24
Number of Participants With Willingness to Re-use Medicine Assessment
Time Frame: Week 8, 16, 24
Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).
Week 8, 16, 24
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Time Frame: Baseline, Week 8, 16, 24
EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline, Week 8, 16, 24
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Time Frame: Baseline, Week 2, 8, 16, 24
PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.
Baseline, Week 2, 8, 16, 24
Percentage of Participants Who Received Rescue Medication
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Number of Days of Rescue Medication Usage Per Week
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Number of Rescue Medication Doses Used Per Week
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Amount of Rescue Medication Taken Per Week
Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Serum Total Nerve Growth Factor (NGF) Levels
Time Frame: Baseline, Week 1, 2, 8, 16, 24
Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.
Baseline, Week 1, 2, 8, 16, 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Neurological Examination Findings
Time Frame: Week 2, 8, 16, Week 24 or early termination
A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.
Week 2, 8, 16, Week 24 or early termination
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Time Frame: Baseline, Week 2, 8, 16, 24
The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.
Baseline, Week 2, 8, 16, 24
Body Temperature
Time Frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Systolic and Diastolic Blood Pressure
Time Frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Heart Rate
Time Frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Respiratory Rate
Time Frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Time Frame: Screening, Day 1, Week 2, 8, 16, 24
Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).
Screening, Day 1, Week 2, 8, 16, 24
Electrocardiogram Parameter: Heart Rate
Time Frame: Screening, Day 1, Week 2, 8, 16, 24
Screening, Day 1, Week 2, 8, 16, 24
Post-void Residual (PVR) Volume
Time Frame: Screening, Week 2, 8, 16, 24
PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.
Screening, Week 2, 8, 16, 24
Number of Participants With Urinalysis Abnormalities
Time Frame: Screening up to Week 24
Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (<1.003 and >1.030), urine pH (<4.5 and >8), protein (>=1 value in qualitative test), glucose (>=1 value in qualitative test), ketones (>=1 value in qualitative test), blood (>=1 value in qualitative test), bilirubin (>=1 value in qualitative test), nitrites (>=1), and leukocyte esterase (>=1) are reported.
Screening up to Week 24
Number of Participants With Laboratory Test Abnormalities
Time Frame: Screening up to Week 24
Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.
Screening up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to 112 days after the last dose (up to Week 24)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Baseline up to 112 days after the last dose (up to Week 24)
Number of Participants With Anti-Drug Antibody (ADA)
Time Frame: Baseline, Week 8, 16, 24
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.
Baseline, Week 8, 16, 24

Collaborators and Investigators

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Sponsor

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.

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)

January 22, 2010

Primary Completion (Actual)

November 17, 2010

Study Completion (Actual)

January 21, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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.

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 Cystitis, Interstitial

Clinical Trials on Tanezumab

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