CompletedNot Applicable

An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain

Taiwan37 participantsStarted 2019-11-06

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

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

Trial details

NCT IDNCT05209906

SponsorMackay Memorial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-15

View on ClinicalTrials.gov More Cancer Pain trials