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Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

NCT01141283 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2012-09-03

Study results available
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Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Conditions

Interventions

DRUG

Buprenorphine transdermal patch

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

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 10 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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-07-31
Completion
2004-07-31

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 NCT01141283 on ClinicalTrials.gov