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

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209906
• Other study ID #: 19MMHIS032e
• Status: Completed
• Start date: November 6, 2019
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Drug:
• Fentanyl Buccal Soluble Film
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.

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients requiring dose titration	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
Secondary	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.	At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Secondary	Subjects' satisfaction	Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment	At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years