NCT01125917

Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 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). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

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

• Back Pain Lower Back Chronic

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: 2004-06-01
• Primary completion: 2005-09-01
• Completion: 2008-01-01
• First posted: 2010-05-19
• Last updated: 2012-09-03
• Results posted: 2010-09-21

Locations

84 sites across 1 country: United States