Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy

The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Oxycodone/Naloxone Controlled-release; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1095
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Alliance Clinical Research
    • Birmingham, Alabama, United States, 35209
      • Alabama Orthopaedic Center, PC
    • Haleyville, Alabama, United States, 35565
      • Winston Technology Research, LLC
    • Huntsville, Alabama, United States, 35801
      • Monte Sano Clinical Research, LLC
    • Mobile, Alabama, United States, 36608
      • Research Facility
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc.
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85020
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85050
      • Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Ortho Surgeons
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Anaheim, California, United States, 92804
      • Physician Alliance Research Center
    • Arcadia, California, United States, 91007
      • Advanced Pain Research Institute
    • Buena Park, California, United States, 90620
      • Southbay Pharma Research
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Carmichael, California, United States, 95608
      • Med Center
    • Castro Valley, California, United States, 94546
      • Advanced Pain Management and Rehabilitation Medical Group, Inc.
    • Chino, California, United States, 91710
      • Catalina Research Institute, LLC
    • Escondido, California, United States, 92025
      • Synergy Clinical Research of Escondido
    • Fresno, California, United States, 93720
      • Valley Research
    • Garden Grove, California, United States, 92843
      • RX Clinical Research, Inc.
    • La Mesa, California, United States, 91942
      • Triwest Research Associates
    • Laguna Hills, California, United States, 92637
      • Pacific Coast Pain Management Center
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Los Angeles, California, United States, 90017
      • L.A. Pain and Wellness Institute
    • Newport Beach, California, United States, 92663
      • Newport Beach Clinical Research Associates, Inc.
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research
    • Redding, California, United States, 96001
      • Northern California Clinical Research Center
    • Riverside, California, United States, 92501
      • Probe Clinical Research Corporation
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Santa Ana, California, United States, 92701
      • Probe Clinical Research Corporation
  • Colorado
    • Denver, Colorado, United States, 80209
      • Denver Internal Medicine Group
    • Wheat Ridge, Colorado, United States, 80033
      • Front Range Clinical Research
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • New England Research Associates, LLC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Bradenton, Florida, United States, 34208
      • Coastal Orthopedics & Pain Management
    • Chiefland, Florida, United States, 32626
      • Southeast Clinical Research, LLC
    • Clearwater, Florida, United States, 33756
      • Innovative Research Of West Florida, Inc.
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Debary, Florida, United States, 32713
      • Omega Research Consultants, LLC
    • Fort Lauderdale, Florida, United States, 33306
      • S & W Clinical Research
    • Gainesville, Florida, United States, 32607
      • Southeastern Integrated Medical, PL
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab & Research Center
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Jacksonville, Florida, United States, 32257
      • Florida Institute of Medical Research
    • Jacksonville, Florida, United States, 32216
      • Southeast Clinical Research, LLC
    • Jupiter, Florida, United States, 33458
      • Drug Study Institute
    • Miami, Florida, United States, 33144
      • Pharma Care Research, Inc.
    • Miami, Florida, United States, 33175
      • Advanced Pharma Cr, Llc
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Peninsula Research, Inc.
    • Sarasota, Florida, United States, 34232
      • Sarasota Clinical Research, LLC
    • Sarasota, Florida, United States, 34238
      • Sarasota Pain Medicine Research
    • Tamarac, Florida, United States, 33319
      • Vita Research Solutions & Medical Center, Inc.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Trinity, Florida, United States, 34655
      • Advanced Research Institute, Inc.
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Park, Florida, United States, 32789
      • National Pain Research Institute, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Independent Neurodiagnostic Clinic
    • Duluth, Georgia, United States, 30096
      • In-Quest Medical Research, LLC
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
    • Marietta, Georgia, United States, 30060
      • Research Facility
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc.
    • Savannah, Georgia, United States, 31406
      • SouthCoast Medical Group
    • Snellville, Georgia, United States, 30078
      • Georgia Clinical Research, LLC
  • Idaho
    • Boise, Idaho, United States, 83702
      • The Pain Center
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
    • Evansville, Indiana, United States, 47714
      • Destiny Clinical Research, LLC
    • Valparaiso, Indiana, United States, 46383
      • Northwest Indiana Center for Clinical Research
  • Kansas
    • Leawood, Kansas, United States, 66211
      • International Clinical Research Institute, Inc.
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc. CTT Consultants, Inc.
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Pain Treatment Center of the Bluegrass
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc.
    • New Orleans, Louisiana, United States, 70115
      • Research Facility
  • Maryland
    • Hollywood, Maryland, United States, 20636
      • Mid-Atlantic Medical Research Centers
    • Pikesville, Maryland, United States, 21208
      • MidAtlantic Pain Medicine Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research, LLC
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research
    • Watertown, Massachusetts, United States, 02472-3930
      • MedVadis Research Corporation
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Cadillac, Michigan, United States, 49601
      • Great Lakes Family Care
    • Pinconning, Michigan, United States, 48650
      • Great Lakes Research Group, Inc.
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
    • St. Louis, Missouri, United States, 63141
      • Mercy Health Research
    • St. Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Research Facility
  • New Jersey
    • Blackwood, New Jersey, United States, 08012
      • South Jersey Medical Associates, P.A.
    • Stratford, New Jersey, United States, 08084
      • University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
  • New York
    • Cedarhurst, New York, United States, 11516
      • Five Towns Neuroscience Research/Five Towns Neurology
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group, LLP
    • New York, New York, United States, 10022
      • Research Across America
    • New York, New York, United States, 10022
      • Medex Healthcare Research, Inc.
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Box Arthritis & Rheumatology of the Carolinas, PLLC
    • Charlotte, North Carolina, United States, 28205
      • Gaffney Health Services
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Medical Clinic, LLC
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Clinical Inquest Center Ltd.
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research, Inc.
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care and Research
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Springfield, Ohio, United States, 45504
      • Hometown Urgent Care and Research
    • Tiffin, Ohio, United States, 44883
      • J L Clinical Research
    • Toledo, Ohio, United States, 43623
      • Bone Joint and Spine Surgeons, Inc.
    • Zanesville, Ohio, United States, 43701
      • Pharmacotherapy Research Associates, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Health Research Institute
    • Oklahoma City, Oklahoma, United States, 73109-3834
      • Neuropsychiatric Center and NPC Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Paradigm Research Professionals, LLC
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
    • Eugene, Oregon, United States, 97404
      • Willamette Valley Clinical Studies
    • Eugene, Oregon, United States, 97401
      • Pain Consultants of Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, LLC
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management, PC
    • Bridgeville, Pennsylvania, United States, 15017
      • Paramount Clinical Research
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Mechanicsburg, Pennsylvania, United States, 17055
      • Central Pennsylvania Clinical Research
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide, LLC
    • Red Lion, Pennsylvania, United States, 17356
      • Dairyland Medical Center
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research, Inc
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Hartwell Research Group, LLC
    • Greenville, South Carolina, United States, 29615
      • Greenville Pharmaceutical Research, Inc.
    • Greer, South Carolina, United States, 29650
      • Internal Medicine Of Greer
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts Wellness Center
  • Tennessee
    • Huntingdon, Tennessee, United States, 38344
      • Integrity Clinical Research, LLC
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Austin, Texas, United States, 78756
      • Austin Center for Clinical Research
    • Corpus Christi, Texas, United States, 78415
      • Corpus Christi Pain Medicine
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77074
      • Southwest Clinical Trials
    • Houston, Texas, United States, 77062
      • Pineloch Medical Clinic
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research, LLC
    • Killeen, Texas, United States, 76543
      • Team Research of Central Texas
    • San Angelo, Texas, United States, 76904
      • West Texas Medical Associates
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
  • Utah
    • Bountiful, Utah, United States, 84010
      • Research Facility
    • Murray, Utah, United States, 84107
      • Summit Pain Management
    • Salt Lake City, Utah, United States, 84102
      • Alpine Medical Group
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Virginia Research Center
    • Virginia Beach, Virginia, United States, 23455
      • Independence Family Medicine
    • Virginia Beach, Virginia, United States, 23454
      • Hilltop Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Universal Research Group

Participation Criteria

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 include:

• Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
• The back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee);
• Subjects must be on opioid analgesic therapy for low back pain which:
• Has been ongoing for at least 4 weeks prior to the screening visit and,
• Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to 160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit. Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion;
• Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study;
• Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point numerical rating scale [NRS]) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
• Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point NRS) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
• Subjects must be willing and able to be compliant with the protocol, capable of subjective evaluation, able to read and understand questionnaires, willing and able to use a diary per protocol, and read, understand, and sign the written informed consent in English.

Exclusion Criteria include:

• Female subjects who are pregnant (positive serum beta human chorionic gonadotropin [β hCG] test) or lactating;
• Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation);
• Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia;
• Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a regular basis;
• Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions;
• Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
• Subjects with a history of opioid, alcohol, medication, or illicit drug abuse or addiction;
• Subjects who have received any investigational medication within 30 days of first dose of study drug;
• Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit;
• Subjects who have received study drug in a clinical study of oxycodone/naloxone controlled-release (OXN or ONU).

Other protocol specific inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OXN; Oxycodone/Naloxone Controlled-release Tablets (OXN)	Drug: Oxycodone/Naloxone Controlled-release; Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours; Other Names: TARGINIQ ER
Placebo Comparator: Placebo; Placebo tablets to match OXN	Drug: Placebo; Placebo tablets to match OXN taken orally every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period	The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.	24 hours (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12	The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.	Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC)	The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.	Week 12
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.	Week 12

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Publications and helpful links

Helpful Links

• TARGINIQ ER Labeling

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Low back pain; Chronic pain; Opioid; Moderate to severe chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: ONU3701