CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 enrolled
Drug / intervention
Buprenorphine +1 moredrug
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.

Search/NCT00531427
NCT00531427Phase 3Completed
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Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee

Purdue Pharma LP·interventional·Posted Sep 18, 2007·Updated Sep 10, 2012

In Brief

A Phase 3 clinical trial evaluating Buprenorphine and Placebo for Chronic Pain and Osteoarthritis of the Knee. Completed, enrolled 567 participants across 87 sites.

Detailed Summary

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Osteoarthritis of the Knee
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2007
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.8 years ago

Interventions

Buprenorphinedrug

transdermal system 10 and 20 applied for 7-day wear

Placebodrug

transdermal system (placebo) applied for 7-day wear