Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
- Registration Number
- NCT01141283
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
- 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
- Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
- Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.
Refer to core study for additional inclusion/exclusion information.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BTDS Buprenorphine transdermal patch Buprenorphine transdermal patch
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events as a Measure of Safety and Tolerability 6 months. Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Arthrocare, Arthritis Care and Research
🇺🇸Phoenix, Arizona, United States
Great Lakes Family Care
🇺🇸Cadillac, Michigan, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Granger Medical Clinic
🇺🇸West Valley City, Utah, United States
Allergy, Asthma, Arthritis & Lung
🇺🇸Daytona Beach, Florida, United States
Advanced Pain Medicine
🇺🇸Bakersfield, California, United States
University Clinical Research Deland
🇺🇸Deland, Florida, United States
Research Facility
🇺🇸Bellevue, Washington, United States
Coastal Medical Research
🇺🇸Orange City, Florida, United States
Beth Israel/Dept. of Pain
🇺🇸New York, New York, United States
Low Country Rheumatology, PA
🇺🇸Charleston, South Carolina, United States
Central Plains Clin-Brown Site
🇺🇸Watertown, South Dakota, United States
University Orthopedics & Sport Medicine Center
🇺🇸State College, Pennsylvania, United States
Vista Medical Research Inc.
🇺🇸Mesa, Arizona, United States
Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
🇺🇸Phoenix, Arizona, United States
San Diego Arthritis & Osteoporosis Medical Clinic
🇺🇸San Diego, California, United States
Orange County Clinical Research
🇺🇸Cypress, California, United States
Primary Care Medical Center
🇺🇸Murray, Kentucky, United States
Hilltop Medical Center
🇺🇸Virginia Beach, Virginia, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Internal Medicine Northwest
🇺🇸Tacoma, Washington, United States