Back to resultsA Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan
Primary Purpose
Breakthrough Cancer Pain
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fentanyl buccal soluble film (FBSF)
Sponsored by
About this trial
This is an interventional treatment trial for Breakthrough Cancer Pain focused on measuring Painkyl®, fentanyl buccal soluble film, dose titration
Eligibility Criteria
Inclusion Criteria:
- a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer;
- b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
- c. at least partial relief of breakthrough pain by use of opioid therapy;
- d. 20 years of age or older;
- e. ability to understand and willingness to sign a written informed consent document;
- f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly;
- g. willing and able to complete patient diary with each pain episode
Exclusion Criteria:
- a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
- b. history of hypersensitivity or intolerance to fentanyl;
- c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
- d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
- e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
- f. abnormal oral mucosa which will impede drug absorption;
- g. currently under other treatments that may alter effect of pain control based on investigator's judgment;
- h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
- i. use of an investigational drug within 4 weeks preceding this study;
- j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fentanyl buccal soluble film (FBSF)
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Optimal dose calculation of Painkyl®
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.
Secondary Outcome Measures
Efficacy Phase : Pain intensity difference at 30 minutes (PID30) after treatment
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
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.
• 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]
Assessed by the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients
Full Information
NCT ID
NCT03669263
First Posted
August 17, 2018
Last Updated
September 11, 2018
Sponsor
Chang Gung Memorial Hospital
Collaborators
TTY Biopharm
1. Study Identification
Unique Protocol Identification Number
NCT03669263
Brief Title
A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan
Official Title
Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
June 23, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
TTY Biopharm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Cancer Pain
Keywords
Painkyl®, fentanyl buccal soluble film, dose titration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl buccal soluble film (FBSF)
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Drug
Intervention Name(s)
Fentanyl buccal soluble film (FBSF)
Other Intervention Name(s)
Painkyl, fentanyl buccal soluble film (FBSF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optimal dose calculation of Painkyl®
Description
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.
Time Frame
Within 2 weeks
Secondary Outcome Measure Information:
Title
Efficacy Phase : Pain intensity difference at 30 minutes (PID30) after treatment
Description
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.
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
Title
Efficacy Phase : Subjects' satisfaction score at 30 minutes after treatment
Description
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.
Time Frame
During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug
Title
The percentage of episodes requiring rescue medications.
Description
• 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."
Time Frame
Within 2 weeks
Title
Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]
Description
Assessed by the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients
Time Frame
From the date of study entry until 30 days after the last dose of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer;
b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
c. at least partial relief of breakthrough pain by use of opioid therapy;
d. 20 years of age or older;
e. ability to understand and willingness to sign a written informed consent document;
f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly;
g. willing and able to complete patient diary with each pain episode
Exclusion Criteria:
a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
b. history of hypersensitivity or intolerance to fentanyl;
c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
f. abnormal oral mucosa which will impede drug absorption;
g. currently under other treatments that may alter effect of pain control based on investigator's judgment;
h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
i. use of an investigational drug within 4 weeks preceding this study;
j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Hsu Wang
Organizational Affiliation
Chang Gung Memorial Hospital, Linkou, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20842024
Citation
Greco MT, Corli O, Montanari M, Deandrea S, Zagonel V, Apolone G; Writing Protocol Committee; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Epidemiology and pattern of care of breakthrough cancer pain in a longitudinal sample of cancer patients: results from the Cancer Pain Outcome Research Study Group. Clin J Pain. 2011 Jan;27(1):9-18. doi: 10.1097/AJP.0b013e3181edc250.
Results Reference
background
PubMed Identifier
21265388
Citation
Rhiner MI, von Gunten CF. Cancer breakthrough pain in the presence of cancer-related chronic pain: fact versus perceptions of health-care providers and patients. J Support Oncol. 2010 Nov-Dec;8(6):232-8. doi: 10.1016/j.suponc.2010.10.006.
Results Reference
background
PubMed Identifier
21215653
Citation
Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6.
Results Reference
background
PubMed Identifier
19940014
Citation
Rauck R, North J, Gever LN, Tagarro I, Finn AL. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol. 2010 Jun;21(6):1308-1314. doi: 10.1093/annonc/mdp541. Epub 2009 Nov 25.
Results Reference
background
PubMed Identifier
32721110
Citation
Chiou TJ, Chao TC, Chao TY, Huang JS, Chang YF, Wang CH. A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. Cancer Rep (Hoboken). 2019 Oct;2(5):e1179. doi: 10.1002/cnr2.1179. Epub 2019 Apr 23.
Results Reference
derived
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A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan
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