Buprenorphine Transdermal System (BTDS) in Subjects w/Moderate-Severe Chronic Pain Due to Osteoarthritis (OA) of Knee

Condition(s) targeted: Chronic Pain; Osteoarthritis of the Knee

Intervention: Buprenorphine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Purdue Pharma LP

Overall contact:
Karen Ventrella, Phone: 1-800-745-7445, Ext: 7387, Email: karen.ventrella@pharma.com

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 pain due to OA of the knee. 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.

Official title: Randomized, Double-Blind, Placebo-Controlled With Open-Label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe,Chronic Pain Due to OA of Knee

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

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

Secondary outcome: The daily number of tablets of non opioid 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: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- subjects with moderate to severe chronic OA pain of the knee (lasting several hours

daily) as their predominant pain condition,

- clinical diagnosis of OA of the knee one year or longer,

- subjects treated within the 14 days prior to screening with non opioid therapy only,

or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,

- subjects whose OA knee pain is not adequately controlled with non opioid analgesic

medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria:

- subjects who have had arthroscopy on either knee or hip within 6 months of entering

the study or open surgery on either knee or hip within 9 months of entering the study,

- subjects who are allergic to buprenorphine or who have 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.

Karen Ventrella, Phone: 1-800-745-7445, Ext: 7387, Email: karen.ventrella@pharma.com

Coastal Clinical Research, Inc., Mobile, Alabama 36608, United States; Terminated

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

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

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

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

Research Facility, Foothill Ranch, California 92610, United States; Terminated

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

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

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

Research Facility, Laguna Hills, California 92653, United States; Recruiting
Art Levine, MD
Art Levine, MD, Principal Investigator

Research Facility, Downey, California 90241, United States; Terminated

Catalina Research Institute, Chino, California 91710, United States; Recruiting
Stephen M. Mohaupt, MD
Stephen M. Mohaupt, MD, Principal Investigator

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

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

Research Facility, Clearwater, Florida 33765, United States; Recruiting
Robert L. Jackson, DO
Robert L. Jackson, DO, Principal Investigator

Research Facility, Largo, Florida 33765, United States; Recruiting
Miguel E. Trevino, MD
Miguel E. Trevino, MD, Principal Investigator

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

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

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

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

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

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

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

Research Facility, Royal Palm, Florida 33411, United States; Recruiting
Jorge I. Acevedo, MD
Jorge I. Acevedo, MD, Principal Investigator

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

Coastal Pain Management, Bradenton, Florida 34209, United States; Recruiting
Nileshkumar Patel, MD
Nileshkumar Patel, MD, Principal Investigator

Research Facility, Miami, Florida 33135, United States; Recruiting
Julio C. Machado, Jr., MD
Julio C. Machado, Jr., MD, Principal Investigator

Research Facility, Venice, Florida 34292, United States; Recruiting
Jeffrey L. Kaine, MD
Jeffrey L. Kaine, MD, Principal Investigator

Research Facility, Decatur, Georgia 30033, United States; Recruiting
Grattan C. Woodson, III, MD
Grattan C. Woodson, III, MD, Principal Investigator

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

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

Research Facility, Atlanta, Georgia 30342, United States; Recruiting
James P. Capo, Jr., MD
James P. Capo, Jr., MD, Principal Investigator

AMR Research Associates, Bogart, Georgia 30622-6821, United States; Recruiting
Daphne L. Blackburn, MD
Daphne L. Blackburn, MD, Principal Investigator

Research Facility, Augusta, Georgia 30901, United States; Recruiting
Hemant K. Yagnick, MD
Hemant K. Yagnick, MD, Principal Investigator

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

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

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

Graves-Gilbert Clinic, Bowling Green, Kentucky 42101, United States; Recruiting
Asad D. Fraser, MD
Asad D. Fraser, MD, Principal Investigator

Research Facility, New Iberia, Louisiana 70563, United States; Recruiting
William A. Cenac, MD
William A. Cenac, MD, Principal Investigator

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

Stat-Lab I, Inc., Baton Rouge, Louisiana 70808, United States; Recruiting
John Clark, MD
John Clark, MD, Principal Investigator

Research Facility, Frederick, Maryland 21702, United States; Recruiting
Nathan Wei, MD
Nathan Wei, MD, Principal Investigator

Research Facility, Springfield, Massachusetts 01103, United States; Recruiting
Adnan M. Dahdul, MD
Adnan M. Dahdul, 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, Brockton, Massachusetts 02301, United States; Recruiting
Renolt A. Samaan, MD
Renolt A. Samaan, MD, Principal Investigator

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

Premier Internal Medicine, Biloxi, Mississippi 39531, United States; Recruiting
Magdy M. Gorgi-Mikhail, MD
Magdy M. Gorgi-Mikhail, MD, Principal Investigator

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

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

Sports Med Consultants PC, St. Louis, Missouri 63141, United States; Recruiting
Larkin T. Wadsworth, III, MD
Larkin T. Wadsworth, III, MD, Principal Investigator

Research Facility, Henderson, Nevada 89014, United States; Terminated

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, Morgantown, North Carolina 28655, United States; Recruiting
Kurian C. Abraham, MD
Kurian C. Abraham, MD, Principal Investigator

Research Facility, Winston-Salem, North Carolina 27103, United States; Recruiting
Richard L. Rauck, MD
Richard L. Rauck, MD, Principal Investigator

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

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

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

Digestive Endoscopy Center, Dayton, Ohio 45415, United States; Recruiting
Teressa Patrick, MD
Teressa Patrick, MD, Principal Investigator

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

Research Facility, Canton, Ohio 44718, United States; Recruiting
Frederick C. Whittier, MD
Frederick C. Whittier, MD, Principal Investigator

Research Facility, Mt. Gilead, Ohio 43338, United States; Recruiting
Paramvir S. Bains, DO
Paramvir S. Bains, DO, Principal Investigator

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

Research Facility, Oklahoma City, Oklahoma 73109, United States; Recruiting
Siavash Nael, MD
Siavash Nael, MD, Principal Investigator

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

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

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

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

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

Oyster Point Family Health Ctr, Lancaster, Pennsylvania 17601, United States; Recruiting
Michael W. Warren, MD
Michael W. Warren, MD, Principal Investigator

Paramount Clinical Research, Bridgeville, Pennsylvania 15017, United States; Recruiting
Cynthia P. Butler, DO
Cynthia P. Butler, DO, Principal Investigator

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

Research Facility, Cranston, Rhode Island 02920, United States; Recruiting
Dennis J. Mikolich, MD
Dennis J. Mikolich, MD, Principal Investigator

Greenville Pharmaceutical Research, Greenville, South Carolina 29415, United States; Recruiting
Andras Koser
Y. Eugene Mironer, MD, Principal Investigator

Arthritis Clinic, PLLC, Jackson, Tennessee 38305, United States; Recruiting
Jacob A. Aelion, MD
Jacob A. Aelion, 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, Sugarland, Texas 77479, United States; Recruiting
Ronald M. Pucillo, MD
Ronald M. Pucillo, MD, Principal Investigator

Research Facility, Austin, Texas 78756, United States; Recruiting
John D. Hudson, MD
John D. Hudson, MD, Principal Investigator

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

Research Facility, Nederland, Texas 77627, United States; Recruiting
Christopher E. Marrero, MD
Christopher E. Marrero, MD, Principal Investigator

Research Facility, San Antonio, Texas 78229, United States; Recruiting
James E. Garrison, III, MD
James E. Garrison, III, MD, Principal Investigator

Research Facility, Colleyville, Texas 76034, United States; Recruiting
Robert A. Strzinek, DO
Robert A. Strzinek, DO, Principal Investigator

Research Facility, Salt Lake City, Utah 84102, United States; Recruiting
Jackson M. Rhudy, MD
Jackson M. Rhudy, MD, Principal Investigator

Independence Family Medicine, Virginia Beach, Virginia 23455, United States; Recruiting
Michael V. Moro, MD
Michael V. Moro, MD, Principal Investigator

NDC Medical Center, Norfolk, Virginia 23502, United States; Recruiting
Neil M. Sullivan, MD
Neil M. Sullivan, MD, Principal Investigator

Pacific Northwest Primary Care, Tacoma, Washington 98405, United States; Recruiting
Laural J. Schaberg, ARNP
Craig Romney, MD, Principal Investigator

Starting date: September 2007
Ending date: April 2009
Last updated: September 11, 2008