Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

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

Summary

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

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

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Analgesics, Opioid; Buprenorphine

Criteria

Inclusion Criteria:

• clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.

• taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

• requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.

• scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.