The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
- Conditions
- Osteoarthritis
- Registration Number
- NCT00315848
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
- Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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
- 225
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
- taking >/=3 opioid doses per day with or without acceptable pain control.
- receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
- Secondary Outcome Measures
Name Time Method Brief Pain Inventory dropouts due to lack of efficacy MOS health survey VAS pain intensity therapeutic response patient preference daily patient diary and number of oxycodone/acetaminophen or placebo tablets taken
Trial Locations
- Locations (10)
MediSphere Medical Research Center, L.L.C.
🇺🇸Evansville, Indiana, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Park Place Therapeutic Center
🇺🇸Plantation, Florida, United States
Phoenix Center for Clinical Research
🇺🇸Phoenix, Arizona, United States
Arthritis Diagnostic and Treatment Center
🇺🇸San Antonio, Texas, United States
Gainesville Clinical Research Center
🇺🇸Gainesville, Florida, United States
Western Integrated Pain Treatment Centers
🇺🇸Westminster, Colorado, United States
Stratton VA Medical Center
🇺🇸Albany, New York, United States
Arizona Research and Education
🇺🇸Phoenix, Arizona, United States