Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
- Registration Number
- NCT00312572
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
- currently have condition requiring a stable regimen of acetaminophen (APAP).
- a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
Other protocol-specific exclusion/inclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTDS 20 Buprenorphine transdermal patch Initial doses (Level 1) of BTDS 20. BTDS10/20 Buprenorphine transdermal patch Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.
- Primary Outcome Measures
Name Time Method The Percentage of Subjects Who Completed the 14-day Double-blind Phase. 14 days The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs \>22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
HealthCare Research LLC
🇺🇸St. Louis, Missouri, United States
Lifespan Research Foundation, Inc.
🇺🇸Miami, Florida, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Southern Drug Research
🇺🇸Birmingham, Alabama, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Miami Beach Anesthesiology Associates
🇺🇸Miami Beach, Florida, United States
Kaiser Permanente
🇺🇸Escondido, California, United States
Univ. of Southern California
🇺🇸Santa Monica, California, United States
Lovelace Scientific Resources
🇺🇸Beverly Hills, California, United States
The Medford Medical Clinic
🇺🇸Medford, Oregon, United States
Renaissance Clinical Research & Hypertension Clinic
🇺🇸Dallas, Texas, United States
The Arthritis and Osteoporosis Center
🇺🇸Orangeburg, South Carolina, United States
Spine Care Southwest.
🇺🇸Houston, Texas, United States
Intermountain Orthopaedics
🇺🇸Boise, Idaho, United States
West Broward Rheumatology Association, Inc.
🇺🇸Tamarac, Florida, United States
Hot Springs Mercy Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Arthritis Center of CT
🇺🇸Waterbury, Connecticut, United States
Neuro Science and Spine Assoc.
🇺🇸Naples, Florida, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Northeast Pain Research Center
🇺🇸Barrington, New Hampshire, United States
Dayton Primary and Urgent Care
🇺🇸Dayton, Ohio, United States
KRK Medical Research
🇺🇸Richardson, Texas, United States
Tucson Orthopedic Institute
🇺🇸Tucson, Arizona, United States
Private Practice
🇺🇸Pine Bluff, Arkansas, United States
Monroe Medical Foundation
🇺🇸Monroe, Wisconsin, United States
Southbay Pharma Research
🇺🇸Buena Park, California, United States
PCM Medical Services
🇺🇸Lansing, Michigan, United States
Community Medical Providers
🇺🇸Clovis, California, United States
Westside Family Medical Center
🇺🇸Kalamazoo, Michigan, United States
The Arthritis Clinic and Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
Bluegrass Orthopaedics
🇺🇸Lexington, Kentucky, United States
Dolby Providers, Inc.
🇺🇸New Orleans, Louisiana, United States
CEDRA Clinical Research,
🇺🇸Austin, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States