Cancer PainNCT05209906
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
An observational study of Cancer Pain, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Fentanyl Buccal Soluble Film
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Nov 2019to 15 Aug 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients experienced breakthrough pain even under around-the-clock narcotic drug treatment.
Who may be able to join
- cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
- a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer;
- at least partial relief of breakthrough pain by use of opioid therapy;
- able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;
- willing and able to complete patient diary with each pain episode.
- 20 to 80 years of age;
Who cannot join
- rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
- history of hypersensitivity or intolerance to fentanyl;
- cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
- psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
- Severe (Grade 4) mucositis (subjects with less than severe mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
- abnormal oral mucosa which will impede drug absorption;
Show all 9Show fewer
- recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
- use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study;
- 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
An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.
- Conditions
- Cancer Pain
- Being tested
- Fentanyl Buccal Soluble Film
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Buccal Soluble FilmDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients requiring dose titration
Percentage of patients requiring dose titration
Measured: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Secondary outcomes (2)
Pain intensity changes at 5, 10, 15, 30 minutes after dosing
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.
Measured: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Subjects' satisfaction
Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment
Measured: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start6 Nov 2019
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Shing Leu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209906
- Sponsor's protocol ID
- 19MMHIS032e
- Status last verified
- Aug 2022
- First submitted
- 24 Dec 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chiang YH, Lien CT, Su WH, Yen TY, Chen YJ, Lai YL, Lim KH, Dai KY, Chung HP, Hung CY, Leu YS. Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control. BMC Palliat Care. 2024 Jun 14;23(1):150. doi: 10.1186/s12904-024-01483-7.
PubMed 38877477
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
- ClinicalTrials.gov ID
- NCT05209906
- Acronym / sponsor ID
- 19MMHIS032e
- Conditions
- Cancer Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 27 Jan 2022 (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.
An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients experienced breakthrough pain even under around-the-clock narcotic drug treatment.
Key inclusion criteria (6 listed)
- cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
- a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer;
- at least partial relief of breakthrough pain by use of opioid therapy;
- able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;
- willing and able to complete patient diary with each pain episode.
Key exclusion criteria (9 listed)
- rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
- history of hypersensitivity or intolerance to fentanyl;
- cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
- psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
- Severe (Grade 4) mucositis (subjects with less than severe 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 FilmEligible 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. | Drug | – |
Primary outcome
Percentage of patients requiring dose titration
Time frame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Percentage of patients requiring dose titration
2 secondary outcomes
Pain intensity changes at 5, 10, 15, 30 minutes after dosing
Time frame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Subjects' satisfaction
Time frame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
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 23 Aug 2022.
- Derived from this study: PubMed 38877477Chiang YH, Lien CT, Su WH, Yen TY, Chen YJ, Lai YL, Lim KH, Dai KY, Chung HP, Hung CY, Leu YS. Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control. BMC Palliat Care. 2024 Jun 14;23(1):150. doi: 10.1186/s12904-024-01483-7.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain, run by Mackay 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 6 inclusion and 9 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 23 Aug 2022. 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?
Percentage of patients requiring dose titration (time frame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years). 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 NCT05209906, which also lists 1 linked publication.
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 23 Aug 2022.