Study Stopped
Terminated early due to administrative reasons unrelated to efficacy or safety.
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
1 other identifier
interventional
660
1 country
85
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2004
85 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
February 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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedResults Posted
Study results publicly available
September 29, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.6 years
April 10, 2006
July 28, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Secondary Outcomes (3)
Mean Daily Number of Supplemental Analgesic Tablets
Double-blind phase (84 days)
Oswestry Disability Index (ODI) Score (V 2.0)
Weeks 4, 8, 12
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
Weeks 4, 8, 12 of the double-blind phase
Study Arms (3)
BTDS 5
ACTIVE COMPARATORBuprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
BTDS 20
EXPERIMENTALBuprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Oxycodone Immediate-Release
EXPERIMENTALOxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Eligibility Criteria
You may qualify if:
- low back pain for 3 months or longer, confirmed by radiographic evidence.
- receiving a stable dose of an opioid analgesic for low back pain.
You may not qualify if:
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (85)
Birmingham Pain Center
Birmingham, Alabama, 35244, United States
Arthritis Clinical Intervention Program
Birmingham, Alabama, 35249, United States
Winston Physician Services, LLC
Haleyville, Alabama, 35565, United States
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
Radiant Research
Phoenix, Arizona, 85029, United States
Advanced Clinical Therapeutics
Tuscon, 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, Inc.
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, Inc.
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
Coastal Medical Research
Port Orange, Florida, 32168, 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, 11070, 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
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, 28860, United States
Arthritis & 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
Related Publications (1)
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.
PMID: 21807566RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
BUP3015 was terminated early due to administrative reasons unrelated to efficacy or safety.
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Hale, MD
Gold Coast Research LLC, Weston, FL, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 11, 2006
Study Start
February 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
September 3, 2012
Results First Posted
September 29, 2010
Record last verified: 2012-08