drugset / Trial / NCT00315887

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

NCT00315887

Phase 3 Completed 250 enrolled Purdue Pharma LP
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
1999-04
Primary completion
Completion
1999-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 5 mg Other
Subject Buprenorphine Other / unclassified 10 mg Other
Subject Buprenorphine Other / unclassified 20 mg Other

Indications