Study Stopped
Terminated early due to administrative reasons.
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
1 other identifier
interventional
354
1 country
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2004
Typical duration for phase_3
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedResults Posted
Study results publicly available
September 21, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.3 years
May 17, 2010
July 28, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
BTDS
EXPERIMENTALBuprenorphine transdermal patch
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (84)
Birmingham Pain Center
Birmingham, Alabama, 35244, United States
Arthritis Clinical Intervention Program
Birmingham, Alabama, 35249, United States
Winston Physician Services, Inc
Haleyville, Alabama, 35565, United States
Arizona Research Center Inc
Phoenix, Arizona, 85023, United States
Radiant Research
Phoenix, Arizona, 85029, United States
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Hot Springs Pain Clinic
Hot Springs, Arkansas, 71913, United States
NuLife Clinical Research, Inc.
Anaheim, California, 92805, United States
Lovelace Scientific Resources
Beverly Hills, California, 90211, United States
Northern California Research Corp
Carmichael, California, 95608, United States
International Clinical Research Network
Chula Vista, California, 91911, United States
Shreenath Clinical Service
Fountain Valley, California, 92708, United States
U of Calif at Davis, Med Ctr, Pain Management Center
Sacramento, California, 95817, United States
Accelovance
San Diego, California, 92108, United States
Southern Colorado Clinic
Pueblo, Colorado, 81008, United States
Chiefland Medical Center
Chiefland, Florida, 32626, United States
University Clinical Research Deland
DeLand, Florida, 32720, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Innovative Research of West Florida, Inc.
Largo, Florida, 33770, United States
Renstar Medical
Ocala, Florida, 34471, United States
Peninsula Research Inc.
Ormond Beach, Florida, 32174, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Gold Coast Research, LLC
Plantation, Florida, 33324, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Georgia Medical Research Institute
Marietta, Georgia, 30060, United States
Atlanta Knee & Shoulder Clinic
Stockbridge, Georgia, 30281, United States
Pain Care Boise
Boise, Idaho, 83702, United States
Idaho Arthritis and Osteoporosis Center
Meridian, Idaho, 83742, United States
Pain and Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610, United States
GFI Research Center
Evansville, Indiana, 47714, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Medical Associates Clinics
Dubuque, Iowa, 52002, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66211, United States
CTT, Inc.
Prairie Village, Kansas, 66206, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
New Orleans Clinical Trial Management Inc.
Metairie, Louisiana, 70006, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
Research Center of Louisiana
New Orleans, Louisiana, 70115, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Future Care Studies
Springfield, Massachusetts, 01103, United States
Rheumatology PC
Kalamazoo, Michigan, 49009, United States
Lake Michigan Clinical Research & Consulting, Inc.
Saint Joseph, Michigan, 49085, United States
Medex Healthcare Research Inc
St Louis, Missouri, 63108, United States
HealthCare Research
St Louis, Missouri, 63141, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Lovelace Scientific Resources
Henderson, Nevada, 89014, United States
Pivotal Research Centers
North Las Vegas, Nevada, 89030, United States
Research Across America
New York, New York, 10022, United States
Pain and Orthopedic Neurology , Charlotte Spine Center,
Charlotte, North Carolina, 28207, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Triangle Orthopaedic Associates
Durham, North Carolina, 27704, United States
Pharmquest
Greensboro, North Carolina, 27401, United States
MedArk Clinical Research
Morgantown, North Carolina, 28655, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Odyssey Research
Bismarck, North Dakota, 58502, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Associated Medical Services Inc
Oklahoma City, Oklahoma, 73112, United States
Keystone Clinical Research
Altoona, Pennsylvania, 16602, United States
Valley Pain Specialists
Bethlehem, Pennsylvania, 18016, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055, United States
BioMedical Research Associates
Shippensburg, Pennsylvania, 17257, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
New England Center Clinical Research
Cranston, Rhode Island, 29200, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118, United States
Brown Clinic
Watertown, South Dakota, 57201, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Tri Cities Medical Research
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Galenos Research
Dallas, Texas, 75251, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Team Research of Central Texas
Harker Heights, Texas, 76548, United States
KRK Medical Research
Richardson, Texas, 75080, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Unlimited Research
San Antonio, Texas, 78233, United States
Texas Medical Research Associates
San Antonio, Texas, 78238, United States
Clinical Trial Network Oaks Medical Center
Spring, Texas, 77386, United States
N. Texas Neuro Research
Wichita Falls, Texas, 76301, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Dean Medical Center
Oregon, Wisconsin, 53575, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
BUP3015S was terminated early due to administrative reasons unrelated to efficacy or safety. There was full evaluation of safety but no evaluation of efficacy.
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Study Officials
- STUDY DIRECTOR
Deborah L Steiner, MD, MS
Purdue Pharma LP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 19, 2010
Study Start
June 1, 2004
Primary Completion
September 1, 2005
Study Completion
January 1, 2008
Last Updated
September 3, 2012
Results First Posted
September 21, 2010
Record last verified: 2012-08