NCT00315445

The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Detailed description

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
DRUG	Placebo oxycodone/acetaminophen tablets	Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
DRUG	OXY/APAP	5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
DRUG	Placebo transdermal patch (TDS)	Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Timeline

• Start date: 1997-12-01
• Primary completion: 1998-05-01
• Completion: 1998-05-01
• First posted: 2006-04-18
• Last updated: 2012-09-03
• Results posted: 2011-08-10

Locations

12 sites across 1 country: United States