Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
- Registration Number
- NCT00320801
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.
This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
- Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 188
- osteoarthritis of the hip, knee, or spine for 1 year or longer.
- taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS 5 Buprenorphine transdermal patch Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear BTDS 20 Buprenorphine transdermal patch Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events (AEs) as a Measure of Safety. Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Southern Oregon Health & Wellness
🇺🇸Medford, Oregon, United States
Sidney Hillman Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
NuLife Clinical Research, Inc.
🇺🇸Anaheim, California, United States
Private Practice
🇺🇸Plainview, New York, United States
Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
🇺🇸St. Cloud, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Wilker/Powers Center for Clinical Studies
🇺🇸St. Cloud, Florida, United States
Crest Clinical Research, Inc
🇺🇸Anaheim, California, United States
Valerius Medical Group & Research Center Inc.
🇺🇸Long Beach, California, United States
University Neurology
🇺🇸Sarasota, Florida, United States
Ocala Rheumatology Research Center
🇺🇸Ocala, Florida, United States
Orange County Clinical Research
🇺🇸Cypress, California, United States
Medical Research Associates
🇺🇸Clearwater, Florida, United States
Orrin M. Troum & Medical Associates
🇺🇸Santa Monica, California, United States
America's Doctor (SMO)
🇺🇸Gurnee, Illinois, United States
Edwards Lake Medical Center
🇺🇸Birmingham, Alabama, United States
Scripps Clinic Ranchro Bernardo
🇺🇸San Diego, California, United States
Mountainview Clinical Research
🇺🇸Denver, Colorado, United States
LifeSpan Clinical Research
🇺🇸Miami, Florida, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Arthritis Northwest
🇺🇸Seattle, Washington, United States
LifeTree Clinical Reseach
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Andwell Research
🇺🇸Laguna Niguel, California, United States
Clinical Investigative Services Med College of Georgia
🇺🇸Augusta, Georgia, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Rheumatogogy Associates of N. Alabama,
🇺🇸Huntsville, Alabama, United States
Drug Research and Analysis Corp.
🇺🇸Montgomery, Alabama, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Central Arkansas Research
🇺🇸Hot Springs, Arkansas, United States
Anesthesiology and Pain Management
🇺🇸Los Gatos, California, United States
Pinnacle Trials, Inc.
🇺🇸Atlanta, Georgia, United States
Dolby Providers, Inc.
🇺🇸New Orleans, Louisiana, United States
Research Center of the Ozarks, , MO
🇺🇸Everton, Missouri, United States
Lake Michigan Clinical Research and Consulting, Inc.
🇺🇸St. Joseph, Michigan, United States
Professional Clinical Research
🇺🇸Cadillac, Michigan, United States
Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
🇺🇸Charlotte, North Carolina, United States
Cherry Hill Orthopedic Surgeons
🇺🇸Cherry Hill, New Jersey, United States
Crescent Medical Assoc.
🇺🇸Astoria, New York, United States
State University of NY at Stonybrook
🇺🇸Stonybrook, New York, United States
Albermarle Family Practice
🇺🇸Elizabeth City, North Carolina, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
Midwest Regional Research
🇺🇸Bellbrook, Ohio, United States
Lyle, Austin Alexander PA
🇺🇸Tulsa, Oklahoma, United States
Keystone Clinical Solutions, Inc.
🇺🇸Altoona, Pennsylvania, United States
Rouge Valley Clinical Research
🇺🇸Medford, Oregon, United States
Arcuri Clinical Research
🇺🇸Philadelphia, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Integrity Clinical Research, LLC (SMO)
🇺🇸Milan, Tennessee, United States
Arthritis Clinic of No. Virginia
🇺🇸Arlington, Virginia, United States
MedSource
🇺🇸Richmond, Virginia, United States
Vantage Clinical Research Group
🇺🇸Lacey, Washington, United States
Clinical Trials Northwest
🇺🇸Yakima, Washington, United States
The Arthritis & Osteoporosis Center
🇺🇸Orangeburg, South Carolina, United States
Alpha Clinical Research
🇺🇸Clarksville, Tennessee, United States
Univeristy of Medicine and Dentistry of New Jersey
🇺🇸Stratford, New Jersey, United States
Research Solutions, LLC
🇺🇸Searcy, Arizona, United States
Meadowbrook Research
🇺🇸Scottsdale, Arizona, United States
Odyssey Research Services
🇺🇸Bismark, North Dakota, United States