Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
- Conditions
- Osteoarthritis
- Interventions
- Drug: Placebo transdermal patch
- Registration Number
- NCT00315458
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
- 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
- 107
- clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
- taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
- requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
- scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS Buprenorphine transdermal patch Buprenorphine transdermal patches 10 or 20 mcg/h Placebo Placebo transdermal patch Placebo to match buprenorphine transdermal patch 10 or 20
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) as a Measure of Safety 483 days For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Avancia Research
🇺🇸Pembroke Pines, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Advanced Pain Management and Rehab Hilltop Med Center
🇺🇸Virginia Beach, Virginia, United States
Clinic for Rheumatic Diseases
🇺🇸Tuscaloosa, Alabama, United States
Southbay Pharma Research
🇺🇸Buena Park, California, United States
MediSphere Medical Research Center
🇺🇸Evansville, Indiana, United States
Winston Physician Services, Inc
🇺🇸Haleyville, Alabama, United States
Private Practice
🇺🇸Muscle Shoals, Alabama, United States
Torrence Clinical Research
🇺🇸Torrance, California, United States
Sentara Medical Group
🇺🇸Virginia Beach, Virginia, United States
Physicians Clinic of Spokane
🇺🇸Spokane, Washington, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Clinical Research Consultants
🇺🇸Birmingham, Alabama, United States
Health Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Quality Research
🇺🇸San Antonio, Texas, United States
Comprehensive Neuroscience Inc
🇺🇸Boynton Beach, Florida, United States
University Clinical Research Deland
🇺🇸Deland, Florida, United States
Georgia Medical Research Institute
🇺🇸Marietta, Georgia, United States
Internal Medicine Northwest
🇺🇸Gurnee, Illinois, United States
University of Louisville Medical/Rheumatology
🇺🇸Louisville, Kentucky, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Bay Area Health Clinic
🇺🇸Bay City, Michigan, United States
Medex Healthcare Research Inc
🇺🇸St Louis, Missouri, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
Keystone Clinical Solutions
🇺🇸Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
BioMedical Research Associates
🇺🇸Shippensburg, Pennsylvania, United States
Low Country Rheumatology
🇺🇸Charleston, South Carolina, United States
CSS Research
🇺🇸Memphis, Tennessee, United States
Prime Care Medical Center
🇺🇸Selmer, Tennessee, United States
Team Research of Central Texas
🇺🇸Harker Heights, Texas, United States
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
The Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Chiefland Medical Center
🇺🇸Chiefland, Florida, United States
Ormond Medical Arts Pharmaceutical Res Ctr
🇺🇸Ormond Beach,, Florida, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
ACRC/Arizona Clinical Research
🇺🇸Tuscon, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Coastal Medical Research
🇺🇸Port Orange, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Gold Coast Research LLC
🇺🇸Weston, Florida, United States
Brown Clinic
🇺🇸Watertown, South Dakota, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States