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Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

NCT01135524 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2012-09-10

Study results available
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Summary

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

Conditions

Interventions

DRUG

Buprenorphine transdermal patch

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

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.

DRUG

Buprenorphine transdermal patch

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

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT01135524 on ClinicalTrials.gov