At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 132 enrolled
Drug / intervention
Buprenorphine transdermal patch +2 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.
A Randomized, Double-blind, Placebo- & Positive-Controlled, Parallel Group, Dose Escalating Study to Evaluate the Effect of Buprenorphine Delivered by Buprenorphine Transdermal System at 10- and 40-mg Dose Levels on QT Intervals in Healthy Adult Volunteers
In Brief
A Phase 1 clinical trial evaluating Buprenorphine transdermal patch, Matching placebo transdermal patch, and 1 other intervention for Healthy Volunteers. Completed, enrolled 132 participants across 1 site.
Detailed Summary
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
Primary CompletionDec 2004
First PostedJun 2010
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.0 years ago
Interventions
Buprenorphine transdermal patchdrug
Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h.
Matching placebo transdermal patchdrug
Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20.
Avelox (moxifloxacin hydrochloride) tabletdrug
Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13