213
Participants
Start Date
December 31, 2008
Primary Completion Date
November 30, 2009
Study Completion Date
January 31, 2010
Fentanyl Buccal Tablet
"FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.~The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).~For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician."
Immediate release oxycodone
"Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.~The maximum single dose would be 60 mg (4 capsules)."
Five Towns Neuroscience Research, Cedarhurst
Upstate Clinical Research Associates, Williamsville
Allegheny Pain Management, Altoona
The Clinical Trial Center, LLC, Jenkintown
CRI Worldwide, Philadelphia
University of Pennsylvania, Philadelphia
Clinical Research Center, West Reading
Columbia Medical Practice, Columbia
MidAtlantic Pain Medicine Center, Pikesville
South Carolina Pharmaceutical Research, Spartanburg
Trident Institute of Medical Research, LLC, North Charleston
Greenville Pharmaceutical Research, Greenville
Taylor Research, Marietta
Drug Studies America, Marietta
Georgia Pain Care, Newnan
South Coast Medical Group, Savannah
Emerald Coast Research Group Inc, Marianna
Compass Research, LLC, Orlando
Gold Coast Research, Plantation
Delray Research Associates, Delray Beach
Clinical Research of West Florida, Tampa
Suncoast Neuroscience Associates, St. Petersburg
Sarasota Pain Medicine Research, Sarasota
Parkway Medical Center, Birmingham
Horizon Research Group, Inc, Mobile
CRC of Jackson, Jackson
The Pain Treatment Center of the Bluegrass, Lexington
Clinical Research Source Inc, Perrysburg
University of Cincinnati Medical Center, Cincinnati
Rehabilitation Associates of Indiana, Indianapolis
Indiana Medical Research, Elkhart
Indiana Pain & Spine Clinic, South Bend
Michigan Neurology Associates PC, Clinton Township
Suburban Clinical Research, Bolingbrook
Knight Center for Integrated Health, Peoria
Millennium Pain Center, Bloomington
Healthcare Research, Florissant
ICRI Inc., Overland Park
Gulf Coast Research Associates, Inc, Baton Rouge
Sun Research Institute, San Antonio
Lovelace Scientific, Austin
Aspen Clinical Research, Orem
Clinical Research Center of Nevada, Las Vegas
Robert Karns, MD a Medical Corporation, Beverly Hills
Catalina Research Institute, LLC, Chino
Loma Linda University Health, Loma Linda
Pacific Coast Pain Management, Laguna Hills
VA Northern California Health, Mather
Pain Research of Oregon, Eugene
New England Research Associates, Trumbull
Lead Sponsor
Cephalon
INDUSTRY