drugset / Trial / NCT00312221

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

NCT00312221

Phase 3 Terminated 418 enrolled Purdue Pharma LP
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2004-04
Primary completion
2005-07
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 5 ug Other
Subject Buprenorphine Other / unclassified 20 ug Other
Subject Oxycodone Other / unclassified 40 mg Oral

Indications