A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan

NACompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 25, 2014

Primary Completion Date

June 23, 2016

Study Completion Date

July 1, 2016

Conditions
Breakthrough Cancer Pain
Interventions
DRUG

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."

Trial Locations (1)

Unknown

Chang Gung Memorial Hospital, Keelung

All Listed Sponsors
collaborator

TTY Biopharm

INDUSTRY

lead

Chang Gung Memorial Hospital

OTHER

NCT03669263 - A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan | Biotech Hunter | Biotech Hunter