Clinical trial NCT05209906: An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Official title: An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients experienced breakthrough pain even under around-the-clock narcotic drug treatment.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
2. 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;
3. at least partial relief of breakthrough pain by use of opioid therapy;
4. able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;
5. willing and able to complete patient diary with each pain episode.
6. 20 to 80 years of age;

Exclusion Criteria:

1. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
2. history of hypersensitivity or intolerance to fentanyl;
3. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
4. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
5. 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);
6. abnormal oral mucosa which will impede drug absorption;
7. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
8. use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study;
9. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.

Primary outcomes:
measure: Percentage of patients requiring dose titration
timeFrame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Secondary outcomes:
measure: Pain intensity changes at 5, 10, 15, 30 minutes after dosing
timeFrame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
measure: Subjects' satisfaction
timeFrame: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
References: