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

NCT ID: NCT05209906

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2022-08-15

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.

Conditions

Cancer Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi-Shing Leu

Head of Otorhinolaryngology Department (ENT)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MacKay Memorial Hospital

New Taipei City, , Taiwan

Countries

Taiwan

References

Chiang YH, Lien CT, Su WH, Yen TY, Chen YJ, Lai YL, Lim KH, Dai KY, Chung HP, Hung CY, Leu YS. Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control. BMC Palliat Care. 2024 Jun 14;23(1):150. doi: 10.1186/s12904-024-01483-7.

Reference Type: DERIVED

PMID: 38877477 (View on PubMed)

Other Identifiers

19MMHIS032e

Identifier Type: -

Identifier Source: org_study_id