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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00315887
Study type Interventional
Source Purdue Pharma LP
Contact
Status Completed
Phase Phase 3
Start date April 1999
Completion date October 1999
View Details
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