Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Acetaminophen, hydrocodone drug combination; Buprenorphine

Criteria

Inclusion Criteria:

• osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Exclusion Criteria:

• 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.