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The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

NCT00315445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2012-09-03

Study results available
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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.

Conditions

Interventions

DRUG

Buprenorphine transdermal patch

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

DRUG

Placebo oxycodone/acetaminophen tablets

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

DRUG

OXY/APAP

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

DRUG

Placebo transdermal patch (TDS)

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

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-12-31
Primary Completion
1998-05-31
Completion
1998-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00315445 on ClinicalTrials.gov