NCT01141283

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2010-06-10
• Last updated: 2012-09-03
• Results posted: 2010-09-21

Locations

42 sites across 1 country: United States