Breakthrough Cancer PainNCT03669263
A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan
A study testing Fentanyl buccal soluble film (FBSF) in people with Breakthrough Cancer Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- What is being tested?
- Fentanyl buccal soluble film (FBSF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2014to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breakthrough Cancer Pain
- Being tested
- Fentanyl buccal soluble film (FBSF)
- Keywords
- Painkyl®, fentanyl buccal soluble film, dose titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl buccal soluble film (FBSF)Drug
Also called Painkyl, 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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl buccal soluble film (FBSF) | Experimental | Single arm Receives: Drug: Fentanyl buccal soluble film (FBSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug
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."
Measured: Within 2 weeks
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
Measured: From the date of study entry until 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start25 Nov 2014
- Primary completion23 Jun 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breakthrough Cancer PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TTY Biopharm
- Responsible party
- Sponsor
- Investigators
- Cheng-Hsu Wang, Study chair, Chang Gung Memorial Hospital, Linkou, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669263
- Sponsor's protocol ID
- PK1302
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20842024Rhiner 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.
PubMed 21265388Mercadante 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.
PubMed 21215653Rauck 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.
PubMed 19940014Chiou 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.
PubMed 32721110
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients
- ClinicalTrials.gov ID
- NCT03669263
- Acronym / sponsor ID
- PK1302
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Painkyl®, fentanyl buccal soluble film, dose titration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- TTY Biopharm
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl buccal soluble film (FBSF) | Experimental | Drug: Fentanyl buccal soluble film (FBSF)Single arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl buccal soluble film (FBSF)Also: Painkyl, 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. | Drug | Fentanyl buccal soluble film (FBSF) |
Primary outcome
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.
4 secondary outcomes
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
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
The percentage of episodes requiring rescue medications.
Time frame: Within 2 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 20842024Greco 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.
- Background: PubMed 21265388Rhiner 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.
- Background: PubMed 21215653Mercadante 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.
- Background: PubMed 19940014Rauck 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.
- Derived from this study: PubMed 32721110Chiou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Hsu Wang study chair
Chang Gung Memorial Hospital, Linkou, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl buccal soluble film (FBSF) in people with Breakthrough Cancer Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal dose calculation of Painkyl® (time frame: Within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669263, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.