Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain - Full Text View

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00490919

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Drug: buprenorphine transdermal delivery systems Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

The 'average pain over the last 24 hours' scores at week 12 of the double-blind phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The daily number of tablets of nonopioid supplemental analgesic medications taken during weeks 2 through 12 of the double-blind phase and the Sleep Disturbance Subscale of the Medical Outcome Study (MOS) Sleep Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	520
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Buprenorphine transdermal delivery system 10 and 20 worn for 7 days	Drug: buprenorphine transdermal delivery systems transdermal delivery system 10 and 20 worn for 7 days
2: Placebo Comparator	Drug: Placebo transdermal delivery system (placebo) worn for 7 days

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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490919

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Locations

United States, Alabama
Research Facility
Anniston, Alabama, United States, 36207
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Research Center Inc.
Phoenix, Arizona, United States, 85023
Radiant Research; Phoenix Southeast
Chandler, Arizona, United States, 85225
Research Facility
Phoenix, Arizona, United States, 85029
Research Facility
Phoenix, Arizona, United States, 85032
United States, California
Research Facility
Anaheim, California, United States, 92801
Research Facility
Carmichael, California, United States, 95608
Research Facility
Foothill Ranch, California, United States, 92610
Research Facility
Sacramento, California, United States, 95831
Lovelace Scientific Resources, Inc.
Beverly Hills, California, United States, 90211
Research Facility
Downey, California, United States, 90241
Advance Care Medical Group
City of Industry, California, United States, 91748
Research Facility
San Luis Obispo, California, United States, 93405
United States, Colorado
Research Facility
Littleton, Colorado, United States, 80128
United States, Connecticut
Research Facility
Stamford, Connecticut, United States, 06905
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Research Facility
Port Orange, Florida, United States, 32127
Century Clinical Research, Inc.
Holly Hill, Florida, United States, 32117-2257
University Clinical Research
Deland, Florida, United States, 32720
Research Facility
West Palm Beach, Florida, United States, 33409
Clinical Research of West Flor
Tampa, Florida, United States, 33603
Research Facility
Tampa, Florida, United States, 33613
Pharmax Research Clinic
Miami, Florida, United States, 33126
Research Facility
Largo, Florida, United States, 33770
Research Facility
Jupiter, Florida, United States, 33458-7200
Research Facility
Merritt Island, Florida, United States, 32953
Research Facility
Clearwater, Florida, United States, 33765
Arthritis Associates of S. FL
Delray Beach, Florida, United States, 33484
Research Facility
Orlando, Florida, United States, 32806
Research Facility
Plantation, Florida, United States, 33324
Research Facility
Ft. Myers, Florida, United States, 33907
United States, Georgia
Independent Neurodiagnostic Clinic
Atlanta, Georgia, United States, 30327
Research Facility
Marietta, Georgia, United States, 30066
Research Facility
Marietta, Georgia, United States, 30060
Druid Oaks Health Center
Decatur, Georgia, United States, 30033
Research Facility
Dawsonville, Georgia, United States, 30534
United States, Hawaii
Research Facility
Honolulu, Hawaii, United States, 96814-4526
United States, Idaho
Research Facility
Boise, Idaho, United States, 83702
United States, Indiana
Rehabilitation Association of IN
Indianapolis, Indiana, United States, 46250
United States, Kansas
CTT Consultants, Inc.
Prairie Village, Kansas, United States, 66206
Research Facility
Overland Park, Kansas, United States, 66211
United States, Louisiana
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
Research Facility
New Orleans, Louisiana, United States, 70114
Research Facility
New Orleans, Louisiana, United States, 70115
Research Facility
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Research Facility
Springfield, Massachusetts, United States, 01103
Research Facility
Brockton, Massachusetts, United States, 02301
East Coast Clinical Research
Haverhill, Massachusetts, United States, 01830-6141
United States, Michigan
Research Facility
Bay City, Michigan, United States, 48706
United States, Mississippi
Research Facility
Biloxi, Mississippi, United States, 39531
United States, Missouri
Research Facility
Florissant, Missouri, United States, 63031
Research Facility
St. Louis, Missouri, United States, 63141
Research Facility
St. Louis, Missouri, United States, 63117
Sports Med Consultants, PC
St. Louis, Missouri, United States, 63141
United States, Nevada
Research Facility
Henderson, Nevada, United States, 89014
Research Facility
Las Vegas, Nevada, United States, 89123
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Research Facility
New York, New York, United States, 10022
Research Facility
New York, New York, United States, 10004
United States, North Carolina
Research Facility
Greensboro, North Carolina, United States, 27401
Research Facility
Morgantown, North Carolina, United States, 28655
Research Facility
Charlotte, North Carolina, United States, 28209
United States, Ohio
Research Facility
Toledo, Ohio, United States, 43623
Community Research
Cincinatti, Ohio, United States, 45245
Research Facility
Columbus, Ohio, United States, 43213
Research Facility
Columbus, Ohio, United States, 43235
Research Facility
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Research Facility
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Research Facility
Eugene, Oregon, United States, 97404
Research Facility
Medford, Oregon, United States, 97504-8311
United States, Pennsylvania
Research Facility
Chicora, Pennsylvania, United States, 16025
Research Facility
West Reading, Pennsylvania, United States, 19611
Research Facility
Duncansville, Pennsylvania, United States, 16635
Research Facility
Mechanicsburg, Pennsylvania, United States, 17055
Research Facility
Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
New England Center for Clinical Research
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Anderson Family Care, PA
Anderson, South Carolina, United States, 29621
United States, Texas
Research Facility
San Antonio, Texas, United States, 78229
Research Facility
Plano, Texas, United States, 75093
KRK Medical Research
Dallas, Texas, United States, 75230
Research Facility
Killeen, Texas, United States, 76543
Research Facility
Sugarland, Texas, United States, 77479
Research Facility
San Antonio, Texas, United States, 78205-1116
United States, Utah
Research Facility
Salt Lake City, Utah, United States, 84106
United States, Virginia
Research Facility
Roanoke, Virginia, United States, 24018

Sponsors and Collaborators

Purdue Pharma LP

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Purdue Pharma L.P. ( Medical Monitor )
Study ID Numbers:	BUP3024
Study First Received:	June 21, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00490919 History of Changes
Health Authority:	United States: Food and Drug Administration