323
Participants
Start Date
July 31, 2007
Primary Completion Date
February 28, 2009
Study Completion Date
February 28, 2009
Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.
Metropolitan Hospital Center, New York
Mount Sinai School of Medicine, New York
Allegheny Pain Management, Altoona
Altoona Center for Clinical Research, Duncansville
University of Pennsylvania, Philadelphia
Mid Atlantic Pain Medicine Center, Pikesville
The Rehabilitation Team West, Baltimore
The Center for Pain Relief, Charleston
Peters Medical Research, High Point
PharmQuest, Greensboro
Raleigh Neurology Associate, Raleigh
Duke University Medical Center, Durham
Greenville Pharmaceutical, Greenville
Taylor Research, LLC, Marietta
DrugStudies America, Marietta
Center for Prospective Outcome Studies, Inc., Atlanta
North Georgia Premier Research, Dawnsonville
AvivoClin Clinical Services, Port Orange
Jacksonville Center for Clinical Research, Jacksonville
Compass Research, Orlando
Stedman Clinical Trials, LLC, Tampa
Lovelace Scientific Resources, Inc., Sarasota
Clinical Research of Tampa Bay, Inc., Spring Hill
Alabama Clinical Therapeutics, Birmingham
Birmingham Pain Center, Birmingham
Comprehensive Pain Specialists, PLLC, Hendersonville
Columbus Clinical Research, Columbus
Rehabilitation Associates of Indiana, Indianapolis
Tristate Arthritis & Rheumatology Center, LLC, Evansville
Integrated Clinical Trial Services, Inc., West Des Moines
International Clinical Research Institute, Inc., Overland Park
Kansas City Bone & Joint Clinic, Inc., Overland Park
Willis-Knighton Pain Management Center, Shreveport
Consultants in Pain Research, San Antonio
InVisions Consultants, LLC, San Antonio
Arizona Research Center, Phoenix
Desert Pain & Rehab Specialists/Redpoint Research, Phoenix
Hope Research Institute, Phoenix
Lovelace Scientific Resources, Inc., Albuquerque
Lovelace Scientific Resources, Inc., Beverly Hills
City of Hope National Medical Center, Duarte
Samaritan Center for Medical Research, Med. Group, Los Gatos
Northwest Clinical Research Center, Bellevue
Advanced Diagnostic Pain Treatment Center, PC, New Haven
Englewood Hospital and Medical Center, Englewood
Lead Sponsor
Cephalon
INDUSTRY