Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
NCT ID: NCT00313014
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
660 participants
INTERVENTIONAL
2004-02-29
2005-09-30
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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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone Immediate-Release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Oxycodone Immediate-Release
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Interventions
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Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone Immediate-Release
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* receiving a stable dose of an opioid analgesic for low back pain.
Exclusion Criteria
* requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
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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Martin Hale, MD
Role: PRINCIPAL_INVESTIGATOR
Gold Coast Research LLC, Weston, FL, USA
Locations
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Birmingham Pain Center
Birmingham, Alabama, United States
Arthritis Clinical Intervention Program
Birmingham, Alabama, United States
Winston Physician Services, LLC
Haleyville, Alabama, United States
Arizona Research Center, Inc.
Phoenix, Arizona, United States
Radiant Research
Phoenix, Arizona, United States
Advanced Clinical Therapeutics
Tuscon, Arizona, United States
Hot Springs Pain Clinic
Hot Springs, Arkansas, United States
NuLife Clinical Research, Inc.
Anaheim, California, United States
Lovelace Scientific Resources, Inc.
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, Inc.
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
Coastal Medical Research
Port Orange, 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
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
Arthritis & 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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References
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Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.
Other Identifiers
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BUP3015
Identifier Type: -
Identifier Source: org_study_id