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

NCT ID: NCT01135524

Last Updated: 2012-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Conditions

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Osteoarthritis

Keywords

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Osteoarthritis Opioid Transdermal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BTDS

Buprenorphine transdermal patch

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

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

Buprenorphine transdermal patch

Intervention Type DRUG

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

Buprenorphine transdermal patch

Intervention Type DRUG

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

Interventions

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Buprenorphine transdermal patch

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

Intervention Type DRUG

Buprenorphine transdermal patch

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

Intervention Type DRUG

Buprenorphine transdermal patch

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

Intervention Type DRUG

Other Intervention Names

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Butrans™ Butrans™ Butrans™

Eligibility Criteria

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Inclusion Criteria

* Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.

Exclusion Criteria

* Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
* Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
* Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alabama Neurology and Pain Medicine

Alabaster, Alabama, United States

Site Status

Research Facility

Birmingham, Alabama, United States

Site Status

The Birmingham Pain Center

Birmingham, Alabama, United States

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University of Alabama Hospital

Birmingham, Alabama, United States

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HealthSouth Metro West Hospital

Fairfield, Alabama, United States

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Research Facility

Phoenix, Arizona, United States

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Arizona Research Center

Phoenix, Arizona, United States

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Research Facility

Phoenix, Arizona, United States

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Research Facility

Tucson, Arizona, United States

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Hot Springs Pain Clinic

Hot Springs, Arkansas, United States

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Research Facility

Buena Park, California, United States

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Research Facility

Chula Vista, California, United States

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Research Facility

Fresno, California, United States

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Los Gatos, California, United States

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Research Facility

Roseville, California, United States

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NTOUCH Research Corporation

San Diego, California, United States

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San Diego, California, United States

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Research Facility

Torrence, California, United States

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Upland, California, United States

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Pueblo, Colorado, United States

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Bridgeport, Connecticut, United States

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Coral Gables, Florida, United States

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Daytona Beach, Florida, United States

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Hialeah, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Ocala, Florida, United States

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Ormond Beach, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Radiant Research

Pinellas Park, Florida, United States

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Research Facility

Plantation, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Research Facility

West Palm Beach, Florida, United States

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Research Facility

Marietta, Georgia, United States

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Research Facility

Boise, Idaho, United States

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Idaho Arthritis Osteoporosis

Meridian, Idaho, United States

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Research Facility

Chicago, Illinois, United States

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Research Facility

Springfield, Illinois, United States

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Integrated Clinical Trials

West Des Moines, Iowa, United States

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Louisville Endocrinology PSC

Louisville, Kentucky, United States

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Research Facility

Madisonville, Kentucky, United States

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Research Facility

New Orleans, Louisiana, United States

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Research Facility

New Orleans, Louisiana, United States

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Dolby Providers

New Orleans, Louisiana, United States

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Research Facility

Baltimore, Maryland, United States

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Patuxent Medical Group

Columbia, Maryland, United States

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Research Facility

Hagerstown, Maryland, United States

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Research Facility

Brockton, Massachusetts, United States

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Crystal Lake Health Center

Benzonia, Michigan, United States

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Rheumatology PC

Kalamazoo, Michigan, United States

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Research Facility

Lansing, Michigan, United States

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KC Pain Centers East

Independence, Missouri, United States

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Research Facility

St Louis, Missouri, United States

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HealthCare Research LLC

St Louis, Missouri, United States

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Research Facility

Las Vegas, Nevada, United States

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Research Facility

Las Vegas, Nevada, United States

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Research Facility

New York, New York, United States

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Research Facility

Syracuse, New York, United States

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The Arthritis Clinic and Carolina Bone and Joint

Charlotte, North Carolina, United States

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Triangle Orthopaedic Associates

Durham, North Carolina, United States

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Research Facility

Greensboro, North Carolina, United States

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Research Facility

Hickory, North Carolina, United States

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Cornerstone Research Care

High Point, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Altoona, Pennsylvania, United States

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Research Facility

Duncansville, Pennsylvania, United States

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The Clinical Trial Center

Jenkintown, Pennsylvania, United States

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Research Facility

Mechanicsburg, Pennsylvania, United States

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New England Center for Clinical Research

Cranston, Rhode Island, United States

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Radiant Research

Greer, South Carolina, United States

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Allergy ARTS

Amarillo, Texas, United States

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Research Facility

Conroe, Texas, United States

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Family Practice Associates

Corpus Christi, Texas, United States

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Research Facility

Dallas, Texas, United States

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Research Facility

Dallas, Texas, United States

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Research Facility

Houston, Texas, United States

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KRK Medical Research

Richardson, Texas, United States

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San Antonio, Texas, United States

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Research Facility

San Antonio, Texas, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Research Facility

New Berlin, Wisconsin, United States

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Countries

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United States

Other Identifiers

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BUP3019S

Identifier Type: -

Identifier Source: org_study_id