Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
- Registration Number
- NCT00324038
- Lead Sponsor
- Napp Pharmaceuticals Limited
- Brief Summary
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
Inclusion Criteria
- Either sex aged 65 or above
- Diagnosis of OA of the hip and/or knee
- Severe pain requiring step two medication
- Taking maximum dose of paracetamol
Exclusion Criteria
- Painful disease of the joints other than OA
- Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
- Subjects taking cyclooxygenase (COX) II selective inhibitors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description codeine paracetamol tablets Codeine paracetamol codeine paracetamol combination tablets buprenorphine transdermal system Buprenorphine Buprenorphine transdermal 7 day analgesic patch
- Primary Outcome Measures
Name Time Method Average Daily Pain Scores - BS11 Pain Scores. every day over a 12 week study duration. The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Napp Pharmaceuticals Ltd
🇬🇧Cambridge, United Kingdom