A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan
|ClinicalTrials.gov Identifier: NCT03669263|
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
To determine the feasible dose range of Painkyl® required for Taiwanese population.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breakthrough Cancer Pain||Drug: Fentanyl buccal soluble film (FBSF)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients|
|Actual Study Start Date :||November 25, 2014|
|Actual Primary Completion Date :||June 23, 2016|
|Actual Study Completion Date :||July 1, 2016|
Experimental: Fentanyl buccal soluble film (FBSF)
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.
Other Name: Painkyl, fentanyl buccal soluble film (FBSF)
- Optimal dose calculation of Painkyl® [ Time Frame: Within 2 weeks ]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.
- Efficacy Phase : Pain intensity difference at 30 minutes (PID30) after treatment [ Time Frame: During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug, at 0 and 10 minutes after taking dose of study drug ]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.
- Efficacy Phase : Subjects' satisfaction score at 30 minutes after treatment [ Time Frame: During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug ]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.
- The percentage of episodes requiring rescue medications. [ Time Frame: Within 2 weeks ]• 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."
- Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] [ Time Frame: From the date of study entry until 30 days after the last dose of study treatment ]Assessed by the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669263
|Chang Gung Memorial Hospital|
|Study Chair:||Cheng-Hsu Wang||Chang Gung Memorial Hospital, Linkou, Taiwan|