CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 189 enrolled
Drug / intervention
Buprenorphine transdermal patchdrug
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/NCT01151098
NCT01151098Phase 3Completed
CompareCT.gov

An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.

Purdue Pharma LP·interventional·Posted Jun 25, 2010·Updated Sep 10, 2012

In Brief

A Phase 3 clinical trial evaluating Buprenorphine transdermal patch for Chronic Nonmalignant Pain. Completed, enrolled 189 participants across 19 sites.

Detailed Summary

The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Nonmalignant Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2010
Enrollment StartApr 1, 2001
Primary CompletionFeb 1, 2002
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.0 years ago

Interventions

Buprenorphine transdermal patchdrug

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