Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
NCT ID: NCT01125917
Last Updated: 2012-09-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
354 participants
INTERVENTIONAL
2004-06-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BTDS
Buprenorphine transdermal patch
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Principal Investigators
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Deborah L Steiner, MD, MS
Role: STUDY_DIRECTOR
Purdue Pharma LP
Locations
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Birmingham Pain Center
Birmingham, Alabama, United States
Arthritis Clinical Intervention Program
Birmingham, Alabama, United States
Winston Physician Services, Inc
Haleyville, Alabama, United States
Arizona Research Center Inc
Phoenix, Arizona, United States
Radiant Research
Phoenix, Arizona, United States
Advanced Clinical Therapeutics
Tucson, Arizona, United States
Hot Springs Pain Clinic
Hot Springs, Arkansas, United States
NuLife Clinical Research, Inc.
Anaheim, California, United States
Lovelace Scientific Resources
Beverly Hills, California, United States
Northern California Research Corp
Carmichael, California, United States
International Clinical Research Network
Chula Vista, California, United States
Shreenath Clinical Service
Fountain Valley, California, United States
U of Calif at Davis, Med Ctr, Pain Management Center
Sacramento, California, United States
Accelovance
San Diego, California, United States
Southern Colorado Clinic
Pueblo, Colorado, United States
Chiefland Medical Center
Chiefland, Florida, United States
University Clinical Research Deland
DeLand, Florida, United States
Drug Study Institute
Jupiter, Florida, United States
Innovative Research of West Florida, Inc.
Largo, Florida, United States
Renstar Medical
Ocala, Florida, United States
Peninsula Research Inc.
Ormond Beach, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Georgia Medical Research Institute
Marietta, Georgia, United States
Atlanta Knee & Shoulder Clinic
Stockbridge, Georgia, United States
Pain Care Boise
Boise, Idaho, United States
Idaho Arthritis and Osteoporosis Center
Meridian, Idaho, United States
Pain and Rehabilitation Clinic of Chicago
Chicago, Illinois, United States
GFI Research Center
Evansville, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Medical Associates Clinics
Dubuque, Iowa, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
CTT, Inc.
Prairie Village, Kansas, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
New Orleans Clinical Trial Management Inc.
Metairie, Louisiana, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, United States
Research Center of Louisiana
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Future Care Studies
Springfield, Massachusetts, United States
Rheumatology PC
Kalamazoo, Michigan, United States
Lake Michigan Clinical Research & Consulting, Inc.
Saint Joseph, Michigan, United States
Medex Healthcare Research Inc
St Louis, Missouri, United States
HealthCare Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Lovelace Scientific Resources
Henderson, Nevada, United States
Pivotal Research Centers
North Las Vegas, Nevada, United States
Research Across America
New York, New York, United States
Pain and Orthopedic Neurology , Charlotte Spine Center,
Charlotte, North Carolina, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Triangle Orthopaedic Associates
Durham, North Carolina, United States
Pharmquest
Greensboro, North Carolina, United States
MedArk Clinical Research
Morgantown, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Odyssey Research
Bismarck, North Dakota, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Associated Medical Services Inc
Oklahoma City, Oklahoma, United States
Keystone Clinical Research
Altoona, Pennsylvania, United States
Valley Pain Specialists
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, United States
BioMedical Research Associates
Shippensburg, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
New England Center Clinical Research
Cranston, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, United States
Brown Clinic
Watertown, South Dakota, United States
Holston Medical Group
Bristol, Tennessee, United States
Tri Cities Medical Research
Bristol, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Galenos Research
Dallas, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Team Research of Central Texas
Harker Heights, Texas, United States
KRK Medical Research
Richardson, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Unlimited Research
San Antonio, Texas, United States
Texas Medical Research Associates
San Antonio, Texas, United States
Clinical Trial Network Oaks Medical Center
Spring, Texas, United States
N. Texas Neuro Research
Wichita Falls, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Dean Medical Center
Oregon, Wisconsin, United States
Countries
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Other Identifiers
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BUP3015S
Identifier Type: -
Identifier Source: org_study_id