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
- Conditions
- Low Back Pain
- Interventions
- Drug: Oxycodone/Naloxone Controlled-releaseDrug: Placebo
- Registration Number
- NCT01358526
- Lead Sponsor
- Purdue Pharma LP
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1095
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OXN Oxycodone/Naloxone Controlled-release Oxycodone/Naloxone Controlled-release Tablets (OXN) Placebo Placebo Placebo tablets to match OXN
- Primary Outcome Measures
Name Time Method The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period 24 hours (Week 12) 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.
- Secondary Outcome Measures
Name Time Method The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 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.
Patient Global Impression of Change (PGIC) Week 12 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.
Trial Locations
- Locations (142)
South Orange County Surgical Medical Group
🇺🇸Laguna Hills, California, United States
Probe Clinical Research Corporation
🇺🇸Santa Ana, California, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Health Care Family Rehab & Research Center
🇺🇸Hialeah, Florida, United States
Sarasota Pain Medicine Research
🇺🇸Sarasota, Florida, United States
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Hartwell Research Group, LLC
🇺🇸Anderson, South Carolina, United States
Pharma Care Research, Inc.
🇺🇸Miami, Florida, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Advanced Pain Research Institute
🇺🇸Arcadia, California, United States
RX Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
TriWest Research Associates
🇺🇸La Mesa, California, United States
Front Range Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
Sarasota Clinical Research, LLC
🇺🇸Sarasota, Florida, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
L.A. Pain and Wellness Institute
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Chino, California, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Valley Research
🇺🇸Fresno, California, United States
Pacific Coast Pain Management Center
🇺🇸Laguna Hills, California, United States
Synergy Clinical Research of Escondido
🇺🇸Escondido, California, United States
Physician Alliance Research Center
🇺🇸Anaheim, California, United States
Med Center
🇺🇸Carmichael, California, United States
Coastal Orthopedics & Pain Management
🇺🇸Bradenton, Florida, United States
Advanced Pain Management and Rehabilitation Medical Group, Inc.
🇺🇸Castro Valley, California, United States
Omega Research Consultants, LLC
🇺🇸Debary, Florida, United States
Southeast Clinical Research, LLC
🇺🇸Jacksonville, Florida, United States
Lotus Clinical Research
🇺🇸Pasadena, California, United States
S & W Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Georgia Institute for Clinical Research, LLC
🇺🇸Marietta, Georgia, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Pain Consultants of Oregon
🇺🇸Eugene, Oregon, United States
Health Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Dedicated Clinical Research
🇺🇸Phoenix, Arizona, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Alabama Orthopaedic Center, PC
🇺🇸Birmingham, Alabama, United States
Denver Internal Medicine Group
🇺🇸Denver, Colorado, United States
Monte Sano Clinical Research, LLC
🇺🇸Huntsville, Alabama, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
National Pain Research Institute, LLC
🇺🇸Winter Park, Florida, United States
Winston Technology Research, LLC
🇺🇸Haleyville, Alabama, United States
Research Facility
🇺🇸Bountiful, Utah, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Radiant Research, Inc.
🇺🇸Chandler, Arizona, United States
Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
🇺🇸Phoenix, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
Ortho Surgeons
🇺🇸Little Rock, Arkansas, United States
Southbay Pharma Research
🇺🇸Buena Park, California, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Northern California Clinical Research Center
🇺🇸Redding, California, United States
New England Research Associates, LLC
🇺🇸Trumbull, Connecticut, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
Peninsula Research, Inc.
🇺🇸Ormond Beach, Florida, United States
Vita Research Solutions & Medical Center, Inc.
🇺🇸Tamarac, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Independent Neurodiagnostic Clinic
🇺🇸Atlanta, Georgia, United States
In-Quest Medical Research, LLC
🇺🇸Duluth, Georgia, United States
Georgia Clinical Research, LLC
🇺🇸Snellville, Georgia, United States
The Pain Center
🇺🇸Boise, Idaho, United States
Clinical Investigation Specialists, Inc.
🇺🇸Gurnee, Illinois, United States
Better Health Clinical Research, Inc.
🇺🇸Newnan, Georgia, United States
Destiny Clinical Research, LLC
🇺🇸Evansville, Indiana, United States
SouthCoast Medical Group
🇺🇸Savannah, Georgia, United States
Northwest Indiana Center for Clinical Research
🇺🇸Valparaiso, Indiana, United States
International Clinical Research Institute, Inc.
🇺🇸Leawood, Kansas, United States
Clinical Trials Technology, Inc. CTT Consultants, Inc.
🇺🇸Prairie Village, Kansas, United States
Mid-Atlantic Medical Research Centers
🇺🇸Hollywood, Maryland, United States
Medvadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
ActivMed Practices and Research
🇺🇸Haverhill, Massachusetts, United States
MidAtlantic Pain Medicine Center
🇺🇸Pikesville, Maryland, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Pinconning, Michigan, United States
Great Lakes Family Care
🇺🇸Cadillac, Michigan, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Sundance Clinical Research, LLC
🇺🇸St. Louis, Missouri, United States
Mercy Health Research
🇺🇸St. Louis, Missouri, United States
University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
🇺🇸Stratford, New Jersey, United States
South Jersey Medical Associates, P.A.
🇺🇸Blackwood, New Jersey, United States
Long Island Gastrointestinal Research Group, LLP
🇺🇸Great Neck, New York, United States
Five Towns Neuroscience Research/Five Towns Neurology
🇺🇸Cedarhurst, New York, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Gaffney Health Services
🇺🇸Charlotte, North Carolina, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
Research Across America
🇺🇸New York, New York, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
🇺🇸Charlotte, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Plains Medical Clinic, LLC
🇺🇸Fargo, North Dakota, United States
Columbus Clinical Research, Inc.
🇺🇸Columbus, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Clinical Inquest Center Ltd.
🇺🇸Beavercreek, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Hometown Urgent Care and Research
🇺🇸Springfield, Ohio, United States
J L Clinical Research
🇺🇸Tiffin, Ohio, United States
Bone Joint and Spine Surgeons, Inc.
🇺🇸Toledo, Ohio, United States
Pharmacotherapy Research Associates, Inc.
🇺🇸Zanesville, Ohio, United States
Neuropsychiatric Center and NPC Research
🇺🇸Oklahoma City, Oklahoma, United States
Paradigm Research Professionals, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Allegheny Pain Management, PC
🇺🇸Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Paramount Clinical Research
🇺🇸Bridgeville, Pennsylvania, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
Dairyland Medical Center
🇺🇸Red Lion, Pennsylvania, United States
New England Center for Clinical Research, Inc
🇺🇸Cranston, Rhode Island, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Greenville Pharmaceutical Research, Inc.
🇺🇸Greenville, South Carolina, United States
Internal Medicine of Greer
🇺🇸Greer, South Carolina, United States
Health Concepts Wellness Center
🇺🇸Rapid City, South Dakota, United States
Corpus Christi Pain Medicine
🇺🇸Corpus Christi, Texas, United States
Integrity Clinical Research, LLC
🇺🇸Huntingdon, Tennessee, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Pineloch Medical Clinic
🇺🇸Houston, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Protenium Clinical Research, LLC
🇺🇸Hurst, Texas, United States
TEAM Research of Central Texas
🇺🇸Killeen, Texas, United States
West Texas Medical Associates
🇺🇸San Angelo, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Summit Pain Management
🇺🇸Murray, Utah, United States
Alpine Medical Group
🇺🇸Salt Lake City, Utah, United States
Hilltop Medical Center
🇺🇸Virginia Beach, Virginia, United States
Independence Family Medicine
🇺🇸Virginia Beach, Virginia, United States
Virginia Research Center
🇺🇸Midlothian, Virginia, United States
Universal Research Group
🇺🇸Tacoma, Washington, United States
Northern California Research
🇺🇸Sacramento, California, United States
Southeastern Integrated Medical, PL
🇺🇸Gainesville, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Advanced Research Institute, Inc.
🇺🇸Trinity, Florida, United States
The Pain Treatment Center of the Bluegrass
🇺🇸Lexington, Kentucky, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States