Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
- Conditions
- Back Pain Lower Back Chronic
- Interventions
- Registration Number
- NCT01125917
- Lead Sponsor
- Purdue Pharma LP
- Brief 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.
- Detailed 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 354
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BTDS Buprenorphine transdermal patch Buprenorphine transdermal patch
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) as a Measure of Safety 52-week extension phase 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Pharmquest
🇺🇸Greensboro, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Shreenath Clinical Service
🇺🇸Fountain Valley, California, United States
Southern Colorado Clinic
🇺🇸Pueblo, Colorado, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Pain Care Boise
🇺🇸Boise, Idaho, United States
Chiefland Medical Center
🇺🇸Chiefland, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Peninsula Research Inc.
🇺🇸Ormond Beach, Florida, United States
NuLife Clinical Research, Inc.
🇺🇸Anaheim, California, United States
Hot Springs Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Northern California Research Corp
🇺🇸Carmichael, California, United States
University Clinical Research Deland
🇺🇸Deland, Florida, United States
Lovelace Scientific Resources
🇺🇸Henderson, Nevada, United States
Georgia Medical Research Institute
🇺🇸Marietta, Georgia, United States
U of Calif at Davis, Med Ctr, Pain Management Center
🇺🇸Sacramento, California, United States
Winston Physician Services, Inc
🇺🇸Haleyville, Alabama, United States
Renstar Medical
🇺🇸Ocala, Florida, United States
New Orleans Clinical Trial Management Inc.
🇺🇸Metairie, Louisiana, United States
The Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Galenos Research
🇺🇸Dallas, Texas, United States
BioMedical Research Associates
🇺🇸Shippensburg, Pennsylvania, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
New England Center Clinical Research
🇺🇸Cranston, Rhode Island, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, 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
Team Research of Central Texas
🇺🇸Harker Heights, Texas, United States
Keystone Clinical Research
🇺🇸Altoona, Pennsylvania, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
Pain and Rehabilitation Clinic of Chicago
🇺🇸Chicago, Illinois, United States
GFI Research Center
🇺🇸Evansville, Indiana, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Idaho Arthritis and Osteoporosis Center
🇺🇸Meridian, Idaho, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Brown Clinic
🇺🇸Watertown, South Dakota, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
The Arthritis and Osteoporosis Center
🇺🇸Orangeburg, South Carolina, United States
N. Texas Neuro Research
🇺🇸Wichita Falls, Texas, United States
Odyssey Research
🇺🇸Bismark, North Dakota, United States
Accelovance
🇺🇸San Diego, California, United States
CTT, Inc.
🇺🇸Prairie Village, Kansas, United States
Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
Arthritis Clinical Intervention Program
🇺🇸Birmingham, Alabama, United States
Arizona Research Center Inc
🇺🇸Phoenix, Arizona, United States
Triangle Orthopaedic Associates
🇺🇸Durham, North Carolina, United States
Pivotal Research Centers
🇺🇸North Las Vegas, Nevada, United States
Associated Medical Services Inc
🇺🇸Oklahoma City, Oklahoma, United States
Texas Medical Research Associates
🇺🇸San Antonio, Texas, United States
Unlimited Research
🇺🇸San Antonio, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Atlanta Knee & Shoulder Clinic
🇺🇸Stockbridge, Georgia, United States
Medical Associates Clinics
🇺🇸Dubuque, Iowa, 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
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, 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
Pain and Orthopedic Neurology , Charlotte Spine Center,
🇺🇸Charlotte, North Carolina, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Research Across America
🇺🇸New York, New York, United States
MedArk Clinical Research
🇺🇸Morgantown, North Carolina, United States
Center for Clinical Research
🇺🇸Winston Salem, North Carolina, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Dean Medical Center
🇺🇸Oregon, Wisconsin, United States
Clinical Trial Network Oaks Medical Center
🇺🇸Spring, Texas, United States
Valley Pain Specialists
🇺🇸Bethlehem, Pennsylvania, United States
Tri Cities Medical Research
🇺🇸Bristol, Tennessee, United States
KRK Medical Research
🇺🇸Richardson, Texas, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States