NCT00315458

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

Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch applied for 7-day wear.
DRUG	Placebo transdermal patch	Placebo to match buprenorphine transdermal patch 10 or 20.

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2006-04-18
• Last updated: 2012-09-03
• Results posted: 2010-09-23

Locations

48 sites across 1 country: United States