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
1 other identifier
interventional
1,095
1 country
151
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 low-back-pain
Started May 2011
Typical duration for phase_3 low-back-pain
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
September 3, 2014
CompletedNovember 11, 2015
October 1, 2015
1.4 years
May 20, 2011
July 29, 2014
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC)
Week 12
Other Outcomes (2)
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
Week 12
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
Week 12
Study Arms (2)
OXN
EXPERIMENTALOxycodone/Naloxone Controlled-release Tablets (OXN)
Placebo
PLACEBO COMPARATORPlacebo tablets to match OXN
Interventions
Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (151)
Alabama Orthopaedic Center, PC
Birmingham, Alabama, 35209, United States
Alliance Clinical Research
Birmingham, Alabama, 35213, United States
Winston Technology Research, LLC
Haleyville, Alabama, 35565, United States
Monte Sano Clinical Research, LLC
Huntsville, Alabama, 35801, United States
Research Facility
Mobile, Alabama, 36608, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Dedicated Clinical Research
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
Phoenix, Arizona, 85050, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Ortho Surgeons
Little Rock, Arkansas, 72205, United States
Orange County Research Institute
Anaheim, California, 92801, United States
Physician Alliance Research Center
Anaheim, California, 92804, United States
Advanced Pain Research Institute
Arcadia, California, 91007, United States
Southbay Pharma Research
Buena Park, California, 90620, United States
Providence Clinical Research
Burbank, California, 91505, United States
Med Center
Carmichael, California, 95608, United States
Advanced Pain Management and Rehabilitation Medical Group, Inc.
Castro Valley, California, 94546, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
Synergy Clinical Research of Escondido
Escondido, California, 92025, United States
Valley Research
Fresno, California, 93720, United States
RX Clinical Research, Inc.
Garden Grove, California, 92843, United States
TriWest Research Associates
La Mesa, California, 91942, United States
Pacific Coast Pain Management Center
Laguna Hills, California, 92637, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Clinical Trials Research
Lincoln, California, 95648, United States
L.A. Pain and Wellness Institute
Los Angeles, California, 90017, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
Lotus Clinical Research
Pasadena, California, 91105, United States
Northern California Clinical Research Center
Redding, California, 96001, United States
Probe Clinical Research Corporation
Riverside, California, 92501, United States
Northern California Research
Sacramento, California, 95821, United States
Probe Clinical Research Corporation
Santa Ana, California, 92701, United States
Denver Internal Medicine Group
Denver, Colorado, 80209, United States
Front Range Clinical Research
Wheat Ridge, Colorado, 80033, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Coastal Orthopedics & Pain Management
Bradenton, Florida, 34208, United States
Southeast Clinical Research, LLC
Chiefland, Florida, 32626, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research Consultants, LLC
DeBary, Florida, 32713, United States
S & W Clinical Research
Fort Lauderdale, Florida, 33306, United States
Southeastern Integrated Medical, PL
Gainesville, Florida, 32607, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
Southeast Clinical Research, LLC
Jacksonville, Florida, 32216, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Pharma Care Research, Inc.
Miami, Florida, 33144, United States
Advanced Pharma CR, LLC
Miami, Florida, 33175, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Sarasota Clinical Research, LLC
Sarasota, Florida, 34232, United States
Sarasota Pain Medicine Research
Sarasota, Florida, 34238, United States
Vita Research Solutions & Medical Center, Inc.
Tamarac, Florida, 33319, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Advanced Research Institute, Inc.
Trinity, Florida, 34655, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
National Pain Research Institute, LLC
Winter Park, Florida, 32789, United States
Independent Neurodiagnostic Clinic
Atlanta, Georgia, 30327, United States
In-Quest Medical Research, LLC
Duluth, Georgia, 30096, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Research Facility
Marietta, Georgia, 30060, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265, United States
SouthCoast Medical Group
Savannah, Georgia, 31406, United States
Georgia Clinical Research, LLC
Snellville, Georgia, 30078, United States
The Pain Center
Boise, Idaho, 83702, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Destiny Clinical Research, LLC
Evansville, Indiana, 47714, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
International Clinical Research Institute, Inc.
Leawood, Kansas, 66211, United States
Clinical Trials Technology, Inc. CTT Consultants, Inc.
Prairie Village, Kansas, 66206, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Research Facility
New Orleans, Louisiana, 70115, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
MidAtlantic Pain Medicine Center
Pikesville, Maryland, 21208, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
ActivMed Practices and Research
Haverhill, Massachusetts, 01830, United States
Medvadis Research Corporation
Watertown, Massachusetts, 02472-3930, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Great Lakes Family Care
Cadillac, Michigan, 49601, United States
Great Lakes Research Group, Inc.
Pinconning, Michigan, 48650, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Research Facility
Las Vegas, Nevada, 89109, United States
South Jersey Medical Associates, P.A.
Blackwood, New Jersey, 08012, United States
University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
Stratford, New Jersey, 08084, United States
Five Towns Neuroscience Research/Five Towns Neurology
Cedarhurst, New York, 11516, United States
Long Island Gastrointestinal Research Group, LLP
Great Neck, New York, 11023, United States
Medex Healthcare Research, Inc.
New York, New York, 10022, United States
Research Across America
New York, New York, 10022, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Gaffney Health Services
Charlotte, North Carolina, 28205, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, 28210, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Clinical Inquest Center Ltd.
Beavercreek, Ohio, 45432, United States
Community Research
Cincinnati, Ohio, 45227, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45432, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Hometown Urgent Care and Research
Springfield, Ohio, 45504, United States
J L Clinical Research
Tiffin, Ohio, 44883, United States
Bone Joint and Spine Surgeons, Inc.
Toledo, Ohio, 43623, United States
Pharmacotherapy Research Associates, Inc.
Zanesville, Ohio, 43701, United States
Neuropsychiatric Center and NPC Research
Oklahoma City, Oklahoma, 73109-3834, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73112, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Pain Consultants of Oregon
Eugene, Oregon, 97401, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, 16602, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Dairyland Medical Center
Red Lion, Pennsylvania, 17356, United States
New England Center for Clinical Research, Inc
Cranston, Rhode Island, 02920, United States
Hartwell Research Group, LLC
Anderson, South Carolina, 29621, United States
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, 29615, United States
Internal Medicine of Greer
Greer, South Carolina, 29650, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
Health Concepts Wellness Center
Rapid City, South Dakota, 57702, United States
Integrity Clinical Research, LLC
Huntingdon, Tennessee, 38344, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
Corpus Christi Pain Medicine
Corpus Christi, Texas, 78415, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Pineloch Medical Clinic
Houston, Texas, 77062, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Protenium Clinical Research, LLC
Hurst, Texas, 76054, United States
TEAM Research of Central Texas
Killeen, Texas, 76543, United States
West Texas Medical Associates
San Angelo, Texas, 76904, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Research Facility
Bountiful, Utah, 84010, United States
Summit Pain Management
Murray, Utah, 84107, United States
Alpine Medical Group
Salt Lake City, Utah, 84102, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Virginia Research Center
Midlothian, Virginia, 23114, United States
Hilltop Medical Center
Virginia Beach, Virginia, 23454, United States
Independence Family Medicine
Virginia Beach, Virginia, 23455, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 23, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
November 11, 2015
Results First Posted
September 3, 2014
Record last verified: 2015-10