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

NCT00313014 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2012-09-03

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 (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Conditions

  • Back Pain Lower Back Chronic

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

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Principal Investigators

  • Martin Hale, MD · Gold Coast Research LLC, Weston, FL, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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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 NCT00313014 on ClinicalTrials.gov