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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

NCT00312221 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2012-09-10

Study results available
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Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Conditions

Interventions

DRUG

Buprenorphine

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

DRUG

Buprenorphine

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

DRUG

oxycodone immediate-release

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2005-07-31
Completion
2005-08-31

Countries

  • United States

Study Locations

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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 NCT00312221 on ClinicalTrials.gov