Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Timeline
- Start
- 2003-04
- Primary completion
- 2004-06
- Completion
- 2004-06
Outcome
Met primary endpoint
registry MEAN Double-blind Placebo: 12.3 (Standard Error 0.77) days MEAN Double-blind BTDS: 17.2 (Standard Error 0.89) days NCT00313846 ↗
registry analysis (superiority or other test); Double-blind Placebo vs Double-blind BTDS; p = .0026; Kaplan-Meier estimate mean NCT00313846 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 5 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 10 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 20 ug | Other |