The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
- Conditions
- Chronic Low Back Pain
- Registration Number
- NCT00315887
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.
- 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
- 250
- clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
- back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
- Secondary Outcome Measures
Name Time Method Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating) incidence of and time to early discontinuation due to lack of efficacy investigator's assessment of therapeutic response dose level at the end of titration
Trial Locations
- Locations (21)
Mid-America Rheumatology Consultants
🇺🇸Overland Park, Kansas, United States
Evergreen Clinical Research
🇺🇸Edmonds, Washington, United States
Gainesville Clinical Research Center
🇺🇸Gainesville, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Center for Clinical Research
🇺🇸Austin, Texas, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Private Practice
🇺🇸Wauwatosa, Wisconsin, United States
The Arthritis Clinic of Northern Virginia
🇺🇸Arlington, Virginia, United States
Riverhills Healthcare
🇺🇸Crestview Hills, Kentucky, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Coastal Medical Research
🇺🇸South Daytona Beach, Florida, United States
Pain Management & Rehabilitation
🇺🇸Terre Haute, Indiana, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
PrecisionMed, Inc.
🇺🇸Las Vegas, Nevada, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Arthritis Center of Connecticut
🇺🇸Waterbury, Connecticut, United States
University Clinical Research
🇺🇸Deland, Florida, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Cornerstone Research Care
🇺🇸High Point, North Carolina, United States
Arthritis & Osteoporosis Treatment & Research Center
🇺🇸Jackson, Mississippi, United States