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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

NCT00312195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

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 (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Conditions

  • Chronic Non-malignant Pain

Interventions

DRUG

Buprenorphine transdermal patch

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

DRUG

Placebo to match BTDS

Placebo to match buprenorphine transdermal patch applied for 7-day wear.

Sponsors & Collaborators

  • Napp Pharmaceuticals Limited

    collaborator INDUSTRY

  • 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
2001-03-31
Primary Completion
2001-07-31
Completion
2001-07-31

Countries

  • United States
  • United Kingdom

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 NCT00312195 on ClinicalTrials.gov