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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01125917
Other study ID # BUP3015S
Secondary ID
Status Terminated
Phase Phase 3
First received May 17, 2010
Last updated August 27, 2012
Start date June 2004
Est. completion date January 2008

Study information

Verified date August 2012
Source Purdue Pharma LP
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 354
Est. completion date January 2008
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

- For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval = 500 milliseconds (msec) would be discontinued from the extension phase

Exclusion Criteria:

- Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Keystone Clinical Research Altoona Pennsylvania
United States NuLife Clinical Research, Inc. Anaheim California
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Valley Pain Specialists Bethlehem Pennsylvania
United States Lovelace Scientific Resources Beverly Hills California
United States Arthritis Clinical Intervention Program Birmingham Alabama
United States Birmingham Pain Center Birmingham Alabama
United States Odyssey Research Bismark North Dakota
United States Pain Care Boise Boise Idaho
United States Holston Medical Group Bristol Tennessee
United States Tri Cities Medical Research Bristol Tennessee
United States Northern California Research Corp Carmichael California
United States Metrolina Medical Research Charlotte North Carolina
United States Pain and Orthopedic Neurology , Charlotte Spine Center, Charlotte North Carolina
United States Pain and Rehabilitation Clinic of Chicago Chicago Illinois
United States Chiefland Medical Center Chiefland Florida
United States International Clinical Research Network Chula Vista California
United States New England Center Clinical Research Cranston Rhode Island
United States Galenos Research Dallas Texas
United States University Clinical Research Deland Deland Florida
United States Medical Associates Clinics Dubuque Iowa
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Triangle Orthopaedic Associates Durham North Carolina
United States GFI Research Center Evansville Indiana
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Benchmark Research Fort Worth Texas
United States Shreenath Clinical Service Fountain Valley California
United States Pharmquest Greensboro North Carolina
United States Winston Physician Services, Inc Haleyville Alabama
United States Team Research of Central Texas Harker Heights Texas
United States Lovelace Scientific Resources Henderson Nevada
United States Hot Springs Pain Clinic Hot Springs Arkansas
United States Drug Study Institute Jupiter Florida
United States Rheumatology PC Kalamazoo Michigan
United States Holston Medical Group Kingsport Tennessee
United States Innovative Research of West Florida, Inc. Largo Florida
United States Commonwealth Biomedical Research, LLC Madisonville Kentucky
United States Georgia Medical Research Institute Marietta Georgia
United States Central Pennsylvania Clinical Research Mechanicsburg Pennsylvania
United States Idaho Arthritis and Osteoporosis Center Meridian Idaho
United States New Orleans Clinical Trial Management Inc. Metairie Louisiana
United States MedArk Clinical Research Morgantown North Carolina
United States Best Clinical Trials, LLC New Orleans Louisiana
United States Louisiana Research Associates, Inc. New Orleans Louisiana
United States Research Center of Louisiana New Orleans Louisiana
United States Research Across America New York New York
United States Pivotal Research Centers North Las Vegas Nevada
United States Renstar Medical Ocala Florida
United States Associated Medical Services Inc Oklahoma City Oklahoma
United States COR Clinical Research, LLC Oklahoma City Oklahoma
United States Meridian Clinical Research, LLC Omaha Nebraska
United States The Arthritis and Osteoporosis Center Orangeburg South Carolina
United States Dean Medical Center Oregon Wisconsin
United States Peninsula Research Inc. Ormond Beach Florida
United States Vince and Associates Clinical Research Overland Park Kansas
United States The Arthritis Center Palm Harbor Florida
United States University Clinical Research, Inc. Pembroke Pines Florida
United States Arizona Research Center Inc Phoenix Arizona
United States Radiant Research Phoenix Arizona
United States Gold Coast Research, LLC Plantation Florida
United States CTT, Inc. Prairie Village Kansas
United States Southern Colorado Clinic Pueblo Colorado
United States Wake Research Associates, LLC Raleigh North Carolina
United States KRK Medical Research Richardson Texas
United States U of Calif at Davis, Med Ctr, Pain Management Center Sacramento California
United States Lake Michigan Clinical Research & Consulting, Inc. Saint Joseph Michigan
United States Lifetree Clinical Research Salt Lake City Utah
United States Benchmark Research San Angelo Texas
United States Texas Medical Research Associates San Antonio Texas
United States Unlimited Research San Antonio Texas
United States Accelovance San Diego California
United States BioMedical Research Associates Shippensburg Pennsylvania
United States Clinical Trial Network Oaks Medical Center Spring Texas
United States Future Care Studies Springfield Massachusetts
United States HealthCare Research St Louis Missouri
United States Medex Healthcare Research Inc St Louis Missouri
United States University Orthopedics Center State College Pennsylvania
United States Atlanta Knee & Shoulder Clinic Stockbridge Georgia
United States Advanced Clinical Therapeutics Tucson Arizona
United States Omega Medical Research Warwick Rhode Island
United States Brown Clinic Watertown South Dakota
United States Palm Beach Research Center West Palm Beach Florida
United States N. Texas Neuro Research Wichita Falls Texas
United States Center for Clinical Research Winston Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) as a Measure of Safety The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015). 52-week extension phase Yes
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