The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
- Conditions
- Back Pain
- Registration Number
- NCT00315874
- 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 chronic low back 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 if applicable, at early termination.
- Secondary Outcome Measures
Name Time Method MOS health survey VAS pain intensity therapeutic response patient preference daily patient diary Brief Pain Inventory dropouts due to lack of efficacy and number of oxycodone/acetaminophen or placebo tablets taken
Trial Locations
- Locations (12)
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Gainesville Clinical Research Center
🇺🇸Gainesville, Florida, United States
Pain Control Ctr Bowman Gray School of Med
🇺🇸Winston-Salem, North Carolina, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
The New York Hospital Cornell Medical Center
🇺🇸New York, New York, United States
Hawthorne & York, Intl, Ltd
🇺🇸Phoenix, Arizona, United States
Arizona Research & Education
🇺🇸Phoenix, Arizona, United States
Atlanta Research Center
🇺🇸Atlanta, Georgia, United States
Rheumatology Associates, Inc.
🇺🇸Indianapolis, Indiana, United States
Park Place Therapeutic Center
🇺🇸Plantation, Florida, United States
Westside Family Medical Center
🇺🇸Kalamazoo, Michigan, United States
NC Clinical Research, Inc.
🇺🇸Raleigh, North Carolina, United States