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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01135524

Public ClinicalTrials.gov record NCT01135524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 8:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01135524
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Purdue Pharma LP
Industry
Enrollment
196 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2004 (Type not available)
Primary completion
Aug 2005 (Actual)
Completion
Aug 2005 (Actual)
Last update posted
Sep 10, 2012

2004 – 2005

United States locations

U.S. sites
89
U.S. states
29
U.S. cities
78
Facility City State ZIP Site status
Alabama Neurology and Pain Medicine Alabaster Alabama 35007 —
Research Facility Birmingham Alabama 35215 —
The Birmingham Pain Center Birmingham Alabama 35244 —
University of Alabama Hospital Birmingham Alabama 35249 —
HealthSouth Metro West Hospital Fairfield Alabama 35064 —
Research Facility Phoenix Arizona 85018 —
Arizona Research Center Phoenix Arizona 85023 —
Research Facility Phoenix Arizona 85029 —
Research Facility Tucson Arizona 85712 —
Hot Springs Pain Clinic Hot Springs Arkansas 71913 —
Research Facility Buena Park California 90620 —
Research Facility Chula Vista California 91911 —
Research Facility Fresno California 93720 —
Research Facility Los Gatos California 95032 —
Research Facility Roseville California 95661 —
NTOUCH Research Corporation San Diego California 92103 —
Research Facility San Diego California 92120 —
Research Facility Torrence California 90505 —
Research Facility Upland California 91786 —
Research Facility Pueblo Colorado 81008 —
Research Facility Bridgeport Connecticut 06606 —
Research Facility Coral Gables Florida 33134 —
Research Facility Daytona Beach Florida 32114 —
Research Facility Hialeah Florida 33013 —
Research Facility Jupiter Florida 99458 —
Research Facility Largo Florida 33770 —
Research Facility Miami Florida 33155 —
Research Facility North Miami Beach Florida 33180 —
Research Facility Ocala Florida 34471 —
Research Facility Ormond Beach Florida 32174 —
Research Facility Palm Harbor Florida 34684 —
Research Facility Pembroke Pines Florida 33024 —
Radiant Research Pinellas Park Florida 33781 —
Research Facility Plantation Florida 33324 —
Research Facility Port Orange Florida 32127 —
Research Facility Tampa Florida 33614 —
Research Facility West Palm Beach Florida 33409 —
Research Facility Marietta Georgia 30060 —
Research Facility Boise Idaho 83702 —
Idaho Arthritis Osteoporosis Meridian Idaho 83642 —
Research Facility Chicago Illinois 60610 —
Research Facility Springfield Illinois 62704 —
Integrated Clinical Trials West Des Moines Iowa 50265 —
Louisville Endocrinology PSC Louisville Kentucky 40213 —
Research Facility Madisonville Kentucky 42431 —
Research Facility New Orleans Louisiana 70114 —
Research Facility New Orleans Louisiana 70115 —
Dolby Providers New Orleans Louisiana 70128 —
Research Facility Baltimore Maryland 21215 —
Patuxent Medical Group Columbia Maryland 21045 —
Research Facility Hagerstown Maryland 21740 —
Research Facility Brockton Massachusetts 02301 —
Crystal Lake Health Center Benzonia Michigan 49616 —
Rheumatology PC Kalamazoo Michigan 49009 —
Research Facility Lansing Michigan 48917 —
KC Pain Centers East Independence Missouri 64055 —
Research Facility St Louis Missouri 63117 —
HealthCare Research LLC St Louis Missouri 63141 —
Research Facility Las Vegas Nevada 89106 —
Research Facility Las Vegas Nevada 89117 —
Research Facility New York New York 10021 —
Research Facility Syracuse New York 13210 —
The Arthritis Clinic and Carolina Bone and Joint Charlotte North Carolina 28210 —
Triangle Orthopaedic Associates Durham North Carolina 27704 —
Research Facility Greensboro North Carolina 27401 —
Research Facility Hickory North Carolina 28601 —
Cornerstone Research Care High Point North Carolina 27262 —
Research Facility Cincinnati Ohio 45241 —
Research Facility Columbus Ohio 43235 —
Research Facility Oklahoma City Oklahoma 73103 —
Research Facility Eugene Oregon 97404 —
Research Facility Altoona Pennsylvania 16602 —
Research Facility Duncansville Pennsylvania 16635 —
The Clinical Trial Center Jenkintown Pennsylvania 19046 —
Research Facility Mechanicsburg Pennsylvania 17055 —
New England Center for Clinical Research Cranston Rhode Island 02920 —
Radiant Research Greer South Carolina 29651 —
Allergy ARTS Amarillo Texas 79124 —
Research Facility Conroe Texas 77304 —
Family Practice Associates Corpus Christi Texas 78411 —
Research Facility Dallas Texas 75218 —
Research Facility Dallas Texas 75251 —
Research Facility Houston Texas 77054 —
KRK Medical Research Richardson Texas 75080 —
Research Facility San Antonio Texas 78217 —
Research Facility San Antonio Texas 78238 —
Research Facility Spokane Washington 99207 —
Research Facility Milwaukee Wisconsin 53218 —
Research Facility New Berlin Wisconsin 53151 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01135524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2012 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01135524 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →