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

An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.

Study Overview

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Drug: Fentanyl Buccal Soluble Film

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients experienced breakthrough pain even under around-the-clock narcotic drug treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 19MMHIS032e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No