Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

• Status: Completed
• Trial end date: 1999-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

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

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.

• receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

Exclusion Criteria:

• receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products

• scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.