At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 204 enrolled
Drug / intervention
Buprenorphine transdermal patchdrug
Likely dose
Not stated in 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.
A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
In Brief
A Phase 3 clinical trial evaluating Buprenorphine transdermal patch for Osteoarthritis. Completed, enrolled 204 participants across 36 sites.
Detailed Summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2003
Primary CompletionJul 2004
First PostedApr 2006
TodayJul 2026
First PostedApr 10, 2006
Enrollment StartJun 1, 2003
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.2 years ago
Interventions
Buprenorphine transdermal patchdrug
Buprenorphine transdermal patch applied for 7-day wear.