218
Participants
Start Date
December 31, 2006
Primary Completion Date
October 31, 2007
Study Completion Date
October 31, 2007
Fentanyl Buccal Tablets
"Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.~Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.~Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily."
SUNY - Stonybrook, Stony Brook
Allegheny Pain Management, PC, Altoona
Altoona Center for Clinical Research, Duncansville
DeGarmo Institute of Medical Research, Greer
Dawsonville Family Medicine, Dawsonville
Stedman Clinical Trials, Tampa
Alliance Medical Research Group, Clearwater
Innovative Research of West Florida, Largo
Lovelace Scientific Resources, Inc., Sarasota
Birmingham Pain Center, Birmingham
Comprehensive Pain Specialists, PLLC, Hendersonville
Rehabilitation Associates of Indiana, Indianapolis
Northwest Indiana Center for Clinical Research, PC, Valparaiso
Elkhart Clinic, LLC, Elkhart
Montana Cancer Specialists, Missoula
Pain and Rehabilitation Clinic of Chicago, Chicago
Millennium Pain Center, Bloomington
ICRI, Inc., Overland Park
Willis-Knighton Pain Management Center, Shreveport
KRK Medical Research, Richardson
BeXar Clinical Trials, LLC, Richardson
Integrative Pain Manage Centers, Westminster
Lifetree Clinical Research, Salt Lake City
Arizona Research Center, Phoenix
Lovelace Scientific Resources Center, Henderson
Clinical Research Center of Nevada, Las Vegas
Lovelace Scientific Resources, Inc., Beverly Hills
Pain Institute of Santa Monica, Santa Monica
Synergy Clinical Research Center, National City
Orange County Clinical Trials, Anaheim
Vertex Clinical Research, Bakersfield
Pain Consultants of Oregon, Eugene
Advanced Diagnostic Pain Treatment Center, New Haven
Lead Sponsor
Cephalon
INDUSTRY