36
Participants
Start Date
November 25, 2014
Primary Completion Date
June 23, 2016
Study Completion Date
July 1, 2016
Fentanyl buccal soluble film (FBSF)
"After screening, eligible subjects were individually titrated to an adequate dose of FBSF (titration period) and continued on this dose as required to control their BTP throughout the maintenance period of the study.~During the dose titration period, subjects were administered with FBSF in a dose escalation manner until a treatment dose was identified (defined as an adequate relief of BTP observed for at least two consecutive episodes). All patient started with a dose of 200 μg and increased by 200 μg in each subsequent episode until an adequate pain relief with tolerable side effects was achieved. Doses above 1200 μg were not allowed."
Chang Gung Memorial Hospital, Keelung
TTY Biopharm
INDUSTRY
Chang Gung Memorial Hospital
OTHER