Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
- Conditions
- Osteoarthritis
- Registration Number
- NCT00314652
- 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 in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 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
- 260
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules 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 Percentage of patients who were treated successfully for pain management a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
- Secondary Outcome Measures
Name Time Method Average pain intensity and patient satisfaction scores Incidence of early discontinuation due to lack of efficacy Time to early discontinuation due to lack of efficacy Dose level at end of titration Investigator's assessment of therapeutic response Diary pain scores
Trial Locations
- Locations (22)
Clinical Research Consultants, Inc.
🇺🇸Trumbull, Connecticut, United States
Hawthorne & York, International, Ltd.
🇺🇸Phoenix, Arizona, United States
San Diego Arthritis and Osteoporosis Research
🇺🇸San Diego, California, United States
Arizona Research Center, LLC
🇺🇸Phoenix, Arizona, United States
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Scripps Clinic Rancho Bernardo
🇺🇸San Diego, California, United States
ACRC/Arizona Clinical Research
🇺🇸Tucson, Arizona, United States
Gainesville Clinical Research Center
🇺🇸Gainesville, Florida, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Mid-South Clinical Research Institute
🇺🇸Memphis, Tennessee, United States
Advanced Clinical Research
🇺🇸Salt Lake City, Utah, United States
University Clinical Research
🇺🇸Deland, Florida, United States
PW Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
New Century Research Center, Ltd.
🇺🇸Beaverbrook, Ohio, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
NJP Clinical Research
🇺🇸Passaic, New Jersey, United States
Westside Family Medical Center
🇺🇸Kalamazoo, Michigan, United States
Gold Coast Research, Inc.
🇺🇸Weston, Florida, United States
Physicians Research Associates Jacksonville
🇺🇸Jacksonville, Florida, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States