Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

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.

Fentanyl buccal soluble film (FBSF)

Cheng-Hsu Wang

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.

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

Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients

Time to "optimal" dose of an open-label study medication in the titration phase. During the dose titration period, subjects were administered with FBSF (Painkyl®) 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.

During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 30 minutes after taking dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID30 is calculated as the difference in pain intensity from time 0 to 30 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 3-point difference is considered as clinically important.

Participants assessed their subjects' satisfaction of treatment efficacy for treated BTP episodes at 30 minutes after taking dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows: poor; fair; good; very good; excellent.

• Percentage of episodes requiring rescue medications: subjects will record whether rescue medication was taken after study medication administration for each episode of BTP, by answering "yes" or "no."

Assessed by the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients

TTY Biopharm

Chang Gung Memorial Hospital

Morphine

Eligible patients will receive Painkyl® for dose of 200, 400, 600, 800, 1000 or 1200 mcg for the treatment of breakthrough pain according to around-the-clock morphine daily dose.

Fentanyl Buccal Soluble Film

An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.

An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain

Percentage of patients requiring dose titration

Pain score at 5, 10, 15, 30 minutes after dosing vs. pain score before dosing. Pain scale (0-10, 0=no pain to 10=worst pain) will be recorded by subject at the time point of before Painkyl dosing, and at 5, 10, 15, 30 minutes after dosing.

Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan	NCT03669263	Breakthrough Ca...	Fentanyl buccal...	20 Years -	Chang Gung Memorial Hospital
A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan	NCT03669263	Breakthrough Ca...	Fentanyl buccal...	20 Years -	Chang Gung Memorial Hospital
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain	NCT05209906	Cancer Pain	Fentanyl Buccal...	20 Years - 80 Years	Mackay Memorial Hospital
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain	NCT05209906	Cancer Pain	Fentanyl Buccal...	20 Years - 80 Years	Mackay Memorial Hospital

Spots Global Cancer Trial Database for fentanyl buccal soluble film