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

NCT05209906 | Completed

• 1 other identifier: 19MMHIS032e
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Subjects' satisfaction

  At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years

Interventions

Fentanyl Buccal Soluble Film DRUG

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• to 80 years of age;

You may not qualify if:

• 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;
• pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

New Taipei City, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38877477 DERIVED

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Otorhinolaryngology Department (ENT)

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 27, 2022
• Study Start: November 6, 2019
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

TW (1)