Breakthrough Cancer Pain Clinical Trial
Official title:
Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients
Primary Objective:
To determine the feasible dose range of Painkyl® required for Taiwanese population.
Secondary Objectives:
To evaluate the efficacy of Painkyl® by calculating squared mean of pain intensity difference
at 30 minutes after taking Painkyl® (SPID30, an 11-point scale).
To evaluate subjects' satisfaction by conducting global evaluation of medication performance
(a 5-point categorical scale).
To identify percentage of episodes requiring rescue medication during maintenance treatment
period.
To evaluate the safety data of Painkyl® for breakthrough pain.
The primary endpoint was the feasible range of FBSF required for Taiwanese population. The
secondary endpoints were the difference in pain intensity at 30 minutes (PID30) after FBSF
administration, subjects' satisfaction, and the percentage of episodes requiring rescue
medications.
Pain intensity was determined using an 11-point numeric scale from 0="no pain" to 10="worst
pain." Patients were assessed with baseline pain as well as pain intensity at 30 minutes
after dosing. The PID30 was obtained by baseline pain score minus score rated 30 minutes
after dosing.
Patient's satisfaction was assessed using a 5-point (poor, fair, good, very good, and
excellent) categorical scale at 30 minutes after taking FBSF with the following question:
"What was your overall satisfaction with the medication?" At each episode of BTP, subjects
recorded whether a rescue medication was taken after administration of FBSF.
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