NCT00313014

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

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	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
DRUG	Buprenorphine	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
DRUG	Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2006-04-11
• Last updated: 2012-09-03
• Results posted: 2010-09-29

Locations

85 sites across 1 country: United States