Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• osteoarthritis of the hip, knee, or spine for 1 year or longer.

• taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

Exclusion Criteria:

• taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.

• requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.