At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 529 enrolled

Drug / intervention

Buprenorphine transdermal patch +1 moredrug

Likely dose

Buprenorphine transdermal patch 20 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.

Search/NCT00313846

NCT00313846Phase 3Completed

Compare CT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

Purdue Pharma LP·interventional·Posted Apr 12, 2006·Updated Sep 3, 2012

In Brief

A Phase 3 clinical trial evaluating Buprenorphine transdermal patch and Placebo for Osteoarthritis. Completed, enrolled 529 participants across 44 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoarthritis

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2003

Primary CompletionJun 2004

First PostedApr 2006

TodayJul 2026

First PostedApr 12, 2006

Enrollment StartApr 1, 2003

Primary CompletionJun 1, 2004

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 20.2 years ago

Interventions

Buprenorphine transdermal patchdrug

Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.

Placebodrug

Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.