Efficacy, Tolerability, Safety of Buprenorphine TDS in Subjects With Moderate to Severe Chronic Low Back Pain

Condition(s) targeted: Low Back Pain

Intervention: buprenorphine transdermal delivery systems (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Purdue Pharma LP

Overall contact:
Rebecca Carew, Phone: 203-588-7638

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 postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The 'average pain over the last 24 hours' scores at week 12 of the double-blind phase.

Secondary outcome: 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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 nonopioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy Exclusion Criteria: 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. Other protocol-specific inclusion/exclusion criteria may apply.

Rebecca Carew, Phone: 203-588-7638

Research Facility, Anniston, Alabama 36207, United States; Recruiting
Vishala L. Chindalore, MD
Vishala L. Chindalore, MD, Principal Investigator

Coastal Clinical Research, Inc., Mobile, Alabama 36608, United States; Recruiting
Michael L. Granberry, MD
Michael L. Granberry, MD, Principal Investigator

Arizona Research Center Inc., Phoenix, Arizona 85023, United States; Recruiting
Joseph S. Gimbel, MD
Joseph S. Gimbel, MD, Principal Investigator

Radiant Research; Phoenix Southeast, Chandler, Arizona 85225, United States; Recruiting
Kyle Patrick, DO
Kyle Patrick, DO, Principal Investigator

Research Facility, Phoenix, Arizona 85029, United States; Recruiting
Herbert Goodman, MD
Herbert Goodman, MD, Principal Investigator

Research Facility, Phoenix, Arizona 85032, United States; Recruiting
Michael W. Loes, MD
Michael W. Loes, MD, Principal Investigator

Research Facility, Anaheim, California 92801, United States; Recruiting
Steve Sitar, MD
Steve Sitar, MD, Principal Investigator

Research Facility, Carmichael, California 95608, United States; Recruiting
John J. Champlin, MD
John J. Champlin, MD, Principal Investigator

Research Facility, Foothill Ranch, California 92610, United States; Recruiting
Bakulkumar K. Patel, MD
Bakulkumar K. Patel, MD, Principal Investigator

Research Facility, Sacramento, California 95831, United States; Recruiting
Douglas G. Young, MD
Douglas G. Young, MD, Principal Investigator

Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States; Recruiting
Adam Karns, MD
Adam Karns, MD, Principal Investigator

Research Facility, Downey, California 90241, United States; Recruiting
Pramod Multani, MD
Pramod Multani, MD, Principal Investigator

Advance Care Medical Group, City of Industry, California 91748, United States; Recruiting
Gene C. Tu, MD
Manoj Patel, MD
Manoj Patel, MD, Principal Investigator

Research Facility, San Luis Obispo, California 93405, United States; Recruiting
Frank Mazzone, MD
Frank Mazzone, MD, Principal Investigator

Research Facility, Littleton, Colorado 80128, United States; Recruiting
Emily Crockett, MD
Emily Crockett, MD, Principal Investigator

Research Facility, Stamford, Connecticut 06905, United States; Recruiting
David Radin, MD
David Radin, MD, Principal Investigator

Research Facility, West Palm Beach, Florida 33409, United States; Recruiting
Isaac Marcadis, MD
Isaac Marcadis, MD, Principal Investigator

Research Facility, Port Orange, Florida 32127, United States; Recruiting
Alexander J. White, MD
Alexander J. White, MD, Principal Investigator

Century Clinical Research, Inc., Holly Hill, Florida 32117-2257, United States; Recruiting
Loray Blair-Britt, MD
Loray Blair-Britt, MD, Principal Investigator

University Clinical Research, Deland, Florida 32720, United States; Recruiting
Bruce Rankin, DO
Bruce Rankin, DO, Principal Investigator

Clinical Research of West Florida, Clearwater, Florida 33765, United States; Recruiting
Elias M. Kolettis, DO
Elias M. Kolettis, DO, Principal Investigator

Clinical Research of West Flor, Tampa, Florida 33603, United States; Recruiting
Paul A. Lunseth, MD
Paul A. Lunseth, MD, Principal Investigator

Research Facility, Tampa, Florida 33613, United States; Recruiting
Mary Stedman, MD
Mary Stedman, MD, Principal Investigator

Pharmax Research Clinic, Miami, Florida 33126, United States; Recruiting
Roger Rousseau, MD
Roger Rousseau, MD, Principal Investigator

Research Facility, Largo, Florida 33770, United States; Recruiting
Miguel E. Trevino, MD
Miguel E. Trevino, MD, Principal Investigator

Research Facility, Jupiter, Florida 33458-7200, United States; Recruiting
Joseph Saponaro, MD
Joseph Saponaro, MD, Principal Investigator

Research Facility, Merritt Island, Florida 32953, United States; Recruiting
Brian B. Walls, MD
Brian B. Walls, MD, Principal Investigator

Research Facility, Ft. Myers, Florida 33907, United States; Recruiting
Angel O. Pietri, MD
Angel O. Pietri, MD, Principal Investigator

Arthritis Associates of S. FL, Delray Beach, Florida 33484, United States; Recruiting
Steven M. Croft, MD
Phillipe Saxe, MD, Principal Investigator

Research Facility, Orlando, Florida 32806, United States; Recruiting
Craig T. Curtis, MD
Craig T. Curtis, MD, Principal Investigator

Research Facility, Plantation, Florida 33324, United States; Recruiting
Martin E. Hale, MD
Martin E. Hale, MD, Principal Investigator

Independent Neurodiagnostic Clinic, Atlanta, Georgia 30327, United States; Recruiting
Larry D Empting, MD
Larry D. Empting, MD, Principal Investigator

Research Facility, Marietta, Georgia 30066, United States; Recruiting
Marvin D. Tark, MD
Thomas Hurd, MD, Principal Investigator

Research Facility, Marietta, Georgia 30060, United States; Recruiting
Arnold J. Weil, MD
Arnold J. Weil, MD, Principal Investigator

Druid Oaks Health Center, Decatur, Georgia 30033, United States; Recruiting
Timothy D. Watts, MD
Grattan Woodson, MD
Grattan Woodson, MD, Principal Investigator

Research Facility, Dawsonville, Georgia 30534, United States; Recruiting
William J. Keating, MD
William J. Keating, MD, Principal Investigator

Research Facility, Honolulu, Hawaii 96814-4526, United States; Recruiting
David Fitz-Patrick, MD
David Fitz-Patrick, MD, Principal Investigator

Research Facility, Boise, Idaho 83702, United States; Recruiting
Paul C. Collins, MD
Paul C. Collins, MD, Principal Investigator

Rehabilitation Association of IN, Indianapolis, Indiana 46250, United States; Recruiting
Marc E. Duerden, MD
Marc E. Duerden, MD, Principal Investigator

CTT Consultants, Inc., Prairie Village, Kansas 66206, United States; Recruiting
Haydn M. Thomas, MD
Elizabeth Thomas, MD, Principal Investigator

Research Facility, Overland Park, Kansas 66211, United States; Recruiting
Atul T. Patel, MD
Atul T. Patel, MD, Principal Investigator

Dolby Research, LLC, Baton Rouge, Louisiana 70809, United States; Recruiting
Daniel Whittington, MD
Daniel Whittington, MD, Principal Investigator

Research Facility, New Orleans, Louisiana 70114, United States; Recruiting
Michael J. Biunno, MD
Michael J. Biunno, MD, Principal Investigator

Research Facility, New Orleans, Louisiana 70115, United States; Recruiting
George Walker, MD
George Walker, MD, Principal Investigator

Research Facility, Springfield, Massachusetts 01103, United States; Recruiting
Adnan M. Dahdul, MD
Adnan M. Dahdul, MD, Principal Investigator

Research Facility, Brockton, Massachusetts 02301, United States; Recruiting
Renolt A. Samaan, MD
Renolt A. Samaan, MD, Principal Investigator

East Coast Clinical Research, Haverhill, Massachusetts 01830-6141, United States; Recruiting
Michael J. McCartney, MD
Michael J. McCartney, MD, Principal Investigator

Research Facility, Bay City, Michigan 48706, United States; Recruiting
Russell J Struble, MD
Russell Struble, MD, Principal Investigator

Research Facility, Biloxi, Mississippi 39531, United States; Recruiting
Magdy Gorgi-Mikhail, MD
Magdy Gorgi-Mikhail, MD, Principal Investigator

Research Facility, Florissant, Missouri 63031, United States; Recruiting
Larry D. Reed, MD
Larry Reed, MD, Principal Investigator

Research Facility, St. Louis, Missouri 63141, United States; Recruiting
Anthony Margherita, MD
Anthony Margherita, MD, Principal Investigator

Research Facility, St. Louis, Missouri 63117, United States; Recruiting
James E. Greenwald, MD
James E. Greenwald, MD, Principal Investigator

Research Facility, Henderson, Nevada 89014, United States; Recruiting
James V. Meli, DO
James V. Meli, DO, Principal Investigator

Research Facility, Las Vegas, Nevada 89123, United States; Recruiting
Vrijendra Kumar, MD
Vrijendra Kumar, MD, Principal Investigator

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States; Recruiting
Paula J. Lane, MD
Paula J. Lane, MD, Principal Investigator

Research Facility, New York, New York 10022, United States; Recruiting
Howard R. Adelglass, MD
Howard R. Adelglass, MD, Principal Investigator

Research Facility, New York, New York 10004, United States; Recruiting
David C. Pulver, MD
David C. Pulver, MD, Principal Investigator

Research Facility, Greensboro, North Carolina 27401, United States; Recruiting
Alexander V. Murray, MD
Alexander Murray, MD, Principal Investigator

Research Facility, Morgantown, North Carolina 28655, United States; Recruiting
Kurian Abraham, MD
Kurian Abraham, MD, Principal Investigator

Research Facility, Charlotte, North Carolina 28209, United States; Recruiting
George L. Raad, MD
George L. Raad, MD, Principal Investigator

Research Facility, Toledo, Ohio 43623, United States; Recruiting
Robert L Kalb, MD
Robert L Kalb, MD, Principal Investigator

Community Research, Cincinatti, Ohio 45245, United States; Recruiting
Tamela S Zimmerman, MD
Tamela S Zimmerman, MD, Principal Investigator

Research Facility, Columbus, Ohio 43213, United States; Recruiting
Samir Arora, MD
Samir Arora, MD, Principal Investigator

Research Facility, Columbus, Ohio 43235, United States; Recruiting
Donald L. McNeil, MD
Donald L. McNeil, MD, Principal Investigator

Research Facility, Cincinnati, Ohio 45242, United States; Recruiting
Gregory M. Gottschlich, MD
Gregory M. Gottschlich, MD, Principal Investigator

Research Facility, Oklahoma City, Oklahoma 73109, United States; Recruiting
Joseph Grillo, MD
Joseph Grillo, MD, Principal Investigator

Research Facility, Eugene, Oregon 97404, United States; Recruiting
Patricia Buchanan, MD
Patricia Buchanan, MD, Principal Investigator

Research Facility, Medford, Oregon 97504-8311, United States; Recruiting
Keith B. Williams, MD
Todd Winter, MD, Principal Investigator

Research Facility, Altoona, Pennsylvania 16602, United States; Recruiting
Michael J Drass, MD
Michael J Drass, MD, Principal Investigator

Research Facility, West Reading, Pennsylvania 19611, United States; Recruiting
Robert M. Griffin, D.O.
Robert M. Griffin, DO, Principal Investigator

Research Facility, Duncansville, Pennsylvania 16635, United States; Recruiting
Alan J. Kivitz, MD
Alan J. Kivitz, MD, Principal Investigator

Research Facility, Mechanicsburg, Pennsylvania 17055, United States; Recruiting
James I. McMillen, MD
James I. McMillen, MD, Principal Investigator

New England Center for Clinical Research, Cranston, Rhode Island 02920, United States; Recruiting
Frank P. Maggiacomo, DO
Frank P. Maggiacomo, DO, Principal Investigator

Anderson Family Care, PA, Anderson, South Carolina 29621, United States; Recruiting
Wajdi A. Dbouk, MD
Wajdi A. Dbouk, MD, Principal Investigator

Research Facility, San Antonio, Texas 78229, United States; Recruiting
Geri E. Poss, MD
Geri E. Poss, MD, Principal Investigator

Research Facility, Plano, Texas 75093, United States; Recruiting
Jeffrey Adelglass, MD
Jeffrey Adelglass, MD, Principal Investigator

KRK Medical Research, Dallas, Texas 75230, United States; Recruiting
Andrew M. Klymiuk, MD
Andrew M. Klymiuk, MD, Principal Investigator

Research Facility, Killeen, Texas 76543, United States; Recruiting
Dave E. Webster, DO
Dave E. Webster, DO, Principal Investigator

Research Facility, Sugarland, Texas 77479, United States; Recruiting
Ronald M. Pucillo, MD
Ronald M. Pucillo, MD, Principal Investigator

Research Facility, San Antonio, Texas 78205-1116, United States; Recruiting
Stephen C. Cohen, MD
Stephen C. Cohen, MD, Principal Investigator

Research Facility, Salt Lake City, Utah 84106, United States; Recruiting
Lynn R Webster, MD
Lynn R Webster, MD, Principal Investigator

Starting date: June 2007
Ending date: August 2008
Last updated: October 29, 2007