Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
1 other identifier
interventional
539
1 country
86
Brief Summary
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 low-back-pain
Started Jun 2007
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
September 9, 2010
CompletedSeptember 10, 2012
September 1, 2012
1.1 years
June 21, 2007
July 15, 2010
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.
Secondary Outcomes (2)
The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase
weeks 2-12
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Weeks 4, 8, 12 of double-blind phase
Study Arms (2)
Double-blind BTDS 10 or 20
EXPERIMENTALBuprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear
Double-blind Placebo TDS
PLACEBO COMPARATORPlacebo transdermal system to match BTDS patches, applied for 7 days
Interventions
Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
Eligibility Criteria
You may qualify if:
- Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
- Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \<5 mg oxycodone (or equivalent) per day,
- Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy
You may not qualify if:
- Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
- Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
- Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (86)
Research Facility
Anniston, Alabama, 36207, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Radiant Research; Phoenix Southeast
Chandler, Arizona, 85225, United States
Arizona Research Center Inc.
Phoenix, Arizona, 85023, United States
Research Facility
Phoenix, Arizona, 85029, United States
Research Facility
Phoenix, Arizona, 85032, United States
Research Facility
Anaheim, California, 92801, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211, United States
Research Facility
Carmichael, California, 95608, United States
Advance Care Medical Group
City of Industry, California, 91748, United States
Research Facility
Downey, California, 90241, United States
Research Facility
Foothill Ranch, California, 92610, United States
Research Facility
Sacramento, California, 95831, United States
Research Facility
San Luis Obispo, California, 93405, United States
Research Facility
Littleton, Colorado, 80128, United States
Research Facility
Stamford, Connecticut, 06905, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Research Facility
Clearwater, Florida, 33765, United States
University Clinical Research
DeLand, Florida, 32720, United States
Arthritis Associates of S. FL
Delray Beach, Florida, 33484, United States
Research Facility
Fort Myers, Florida, 33907, United States
Century Clinical Research, Inc.
Holly Hill, Florida, 32117-2257, United States
Research Facility
Jupiter, Florida, 33458-7200, United States
Research Facility
Largo, Florida, 33770, United States
Research Facility
Merritt Island, Florida, 32953, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Research Facility
Orlando, Florida, 32806, United States
Research Facility
Plantation, Florida, 33324, United States
Research Facility
Port Orange, Florida, 32127, United States
Clinical Research of West Flor
Tampa, Florida, 33603, United States
Research Facility
Tampa, Florida, 33613, United States
Research Facility
West Palm Beach, Florida, 33409, United States
Independent Neurodiagnostic Clinic
Atlanta, Georgia, 30327, United States
Research Facility
Dawsonville, Georgia, 30534, United States
Druid Oaks Health Center
Decatur, Georgia, 30033, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Marietta, Georgia, 30066, United States
Research Facility
Honolulu, Hawaii, 96814-4526, United States
Research Facility
Boise, Idaho, 83702, United States
Rehabilitation Association of IN
Indianapolis, Indiana, 46250, United States
Research Facility
Overland Park, Kansas, 66211, United States
CTT Consultants, Inc.
Prairie Village, Kansas, 66206, United States
Dolby Research, LLC
Baton Rouge, Louisiana, 70809, United States
Research Facility
New Orleans, Louisiana, 70114, United States
Research Facility
New Orleans, Louisiana, 70115, United States
Research Facility
Shreveport, Louisiana, 71103, United States
Research Facility
Brockton, Massachusetts, 02301, United States
East Coast Clinical Research
Haverhill, Massachusetts, 01830-6141, United States
Research Facility
Springfield, Massachusetts, 01103, United States
Research Facility
Bay City, Michigan, 48706, United States
Research Facility
Biloxi, Mississippi, 39531, United States
Research Facility
Florissant, Missouri, 63031, United States
Research Facility
St Louis, Missouri, 63117, United States
Research Facility
St Louis, Missouri, 63141, United States
Sports Med Consultants, PC
St Louis, Missouri, 63141, United States
Research Facility
Henderson, Nevada, 89014, United States
Research Facility
Las Vegas, Nevada, 89123, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Research Facility
New York, New York, 10004, United States
Research Facility
New York, New York, 10022, United States
Research Facility
Charlotte, North Carolina, 28209, United States
Research Facility
Greensboro, North Carolina, 27401, United States
Research Facility
Morgantown, North Carolina, 28655, United States
Research Facility
Cincinnati, Ohio, 45242, United States
Community Research
Cincinnati, Ohio, 45245, United States
Research Facility
Columbus, Ohio, 43213, United States
Research Facility
Columbus, Ohio, 43235, United States
Research Facility
Toledo, Ohio, 43623, United States
Research Facility
Oklahoma City, Oklahoma, 73109, United States
Research Facility
Eugene, Oregon, 97404, United States
Research Facility
Medford, Oregon, 97504-8311, United States
Research Facility
Altoona, Pennsylvania, 16602, United States
Research Facility
Chicora, Pennsylvania, 16025, United States
Research Facility
Duncansville, Pennsylvania, 16635, United States
Research Facility
Mechanicsburg, Pennsylvania, 17055, United States
Research Facility
West Reading, Pennsylvania, 19611, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Anderson Family Care, PA
Anderson, South Carolina, 29621, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Research Facility
Killeen, Texas, 76543, United States
Research Facility
Plano, Texas, 75093, United States
Research Facility
San Antonio, Texas, 78205-1116, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Sugarland, Texas, 77479, United States
Research Facility
Salt Lake City, Utah, 84106, United States
Research Facility
Roanoke, Virginia, 24018, United States
Related Publications (1)
Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011 Dec;42(6):903-17. doi: 10.1016/j.jpainsymman.2011.04.006. Epub 2011 Sep 25.
PMID: 21945130RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 25, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2008
Study Completion
October 1, 2008
Last Updated
September 10, 2012
Results First Posted
September 9, 2010
Record last verified: 2012-09