CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 134 enrolled
Drug / intervention
Buprenorphine transdermal patch +3 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/NCT00315445
NCT00315445Phase 3Completed
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A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

Purdue Pharma LP·interventional·Posted Apr 18, 2006·Updated Sep 3, 2012

In Brief

A Phase 3 clinical trial evaluating Buprenorphine transdermal patch, Placebo oxycodone/acetaminophen tablets, and 2 other interventions for Back Pain. Completed, enrolled 134 participants across 12 sites.

Detailed Summary

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2006
Enrollment StartDec 1, 1997
Primary CompletionMay 1, 1998
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.2 years ago

Interventions

Buprenorphine transdermal patchdrug

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

Placebo oxycodone/acetaminophen tabletsdrug

Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

OXY/APAPdrug

5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.

Placebo transdermal patch (TDS)drug

Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear