NCT01135524

Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

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 5 mcg/h applied transdermally for 7-day wear.
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.

Timeline

• Start date: 2004-04-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2010-06-02
• Last updated: 2012-09-10
• Results posted: 2010-09-23

Locations

89 sites across 1 country: United States