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Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

NCT00320801 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2012-09-03

Study results available
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Summary

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Conditions

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Principal Investigators

  • Sarah O'Keefe, BSN · Purdue Pharma L.P., Stamford, CT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
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 NCT00320801 on ClinicalTrials.gov