Status:
COMPLETED
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Cancer Pain
Eligibility:
All Genders
20-80 years
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
- 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;
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05209906
Start Date
November 6 2019
End Date
August 15 2022
Last Update
August 23 2022
Active Locations (1)
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1
MacKay Memorial Hospital
New Taipei City, Taiwan