NCT00315887

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

A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (planned)
• 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 and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to 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. 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

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal delivery system

Timeline

• Start date: 1999-04-01
• Completion: 1999-10-01
• First posted: 2006-04-19
• Last updated: 2006-05-03

Locations

22 sites across 1 country: United States