drugset / Trial / NCT00313846

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

NCT00313846

Phase 3 Completed 529 enrolled Purdue Pharma LP
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Timeline

Start
2003-04
Primary completion
2004-06
Completion
2004-06

Drugs

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

Indications