At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 290 enrolled
Drug / intervention
Buprenorphine transdermal patch +2 moredrug
Likely dose
Buprenorphine transdermal patch 5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase
In Brief
A Phase 3 clinical trial evaluating Buprenorphine transdermal patch for Osteoarthritis. Completed, enrolled 290 participants across 42 sites.
Detailed Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2003
Primary CompletionJul 2004
First PostedJun 2010
TodayJul 2026
First PostedJun 10, 2010
Enrollment StartApr 1, 2003
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago
Interventions
Buprenorphine transdermal patchdrug
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patchdrug
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Buprenorphine transdermal patchdrug
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear