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

Completed

• Conditions: Cancer Pain

• Registration Number: NCT05209906
• Lead Sponsor: Mackay Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Status Verified: 2022-08
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients requiring dose titration	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

Secondary Outcome Measures

Name	Time	Method
Pain intensity changes at 5, 10, 15, 30 minutes after dosing	At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years	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.
Subjects' satisfaction	At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years	Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment

Trial Locations

Locations (1)

MacKay Memorial Hospital; 🇨🇳 New Taipei City, Taiwan