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Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

NCT00315458 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2012-09-03

Study results available
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Summary

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Conditions

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch applied for 7-day wear.

DRUG

Placebo transdermal patch

Placebo to match buprenorphine transdermal patch 10 or 20.

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2005-03-31
Completion
2005-03-31

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 NCT00315458 on ClinicalTrials.gov