A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan

NCT03669263 | Completed DMC

• 1 other identifier: PK1302
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine the feasible dose range of Painkyl® required for Taiwanese population. Secondary Objectives: To evaluate the efficacy of Painkyl® by calculating squared mean of pain intensity difference at 30 minutes after taking Painkyl® (SPID30, an 11-point scale). To evaluate subjects' satisfaction by conducting global evaluation of medication performance (a 5-point categorical scale). To identify percentage of episodes requiring rescue medication during maintenance treatment period. To evaluate the safety data of Painkyl® for breakthrough pain.

Conditions

Breakthrough Cancer Pain

Keywords

Painkyl®; fentanyl buccal soluble film; dose titration

Outcome Measures

Primary Outcomes (1)

• Optimal dose calculation of Painkyl®

  Time to "optimal" dose of an open-label study medication in the titration phase. During the dose titration period, subjects were administered with FBSF (Painkyl®) in a dose escalation manner until a treatment dose was identified (defined as an adequate relief of BTP observed for at least two consecutive episodes). All patient started with a dose of 200 μg and increased by 200 μg in each subsequent episode until an adequate pain relief with tolerable side effects was achieved.

  Within 2 weeks

Secondary Outcomes (4)

• Efficacy Phase : Pain intensity difference at 30 minutes (PID30) after treatment

  During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug, at 0 and 10 minutes after taking dose of study drug

• Efficacy Phase : Subjects' satisfaction score at 30 minutes after treatment

  During the efficacy phase, at each episode of breakthrough pain, 30 minutes after taking dose of study drug

• The percentage of episodes requiring rescue medications.

  Within 2 weeks

• Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]

  From the date of study entry until 30 days after the last dose of study treatment

Study Arms (1)

Fentanyl buccal soluble film (FBSF)

EXPERIMENTAL

Single arm

Drug: Fentanyl buccal soluble film (FBSF)

Interventions

Fentanyl buccal soluble film (FBSF) DRUG

After screening, eligible subjects were individually titrated to an adequate dose of FBSF (titration period) and continued on this dose as required to control their BTP throughout the maintenance period of the study. During the dose titration period, subjects were administered with FBSF in a dose escalation manner until a treatment dose was identified (defined as an adequate relief of BTP observed for at least two consecutive episodes). All patient started with a dose of 200 μg and increased by 200 μg in each subsequent episode until an adequate pain relief with tolerable side effects was achieved. Doses above 1200 μg were not allowed.

Also known as: Painkyl, fentanyl buccal soluble film (FBSF)

Fentanyl buccal soluble film (FBSF)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. a stable current regimen of oral opioids equivalent to 60-1000 mg/day of oral morphine or 20-120 mg/day of iv morphine or 25-300 mcg/hr of transdermal fentanyl for one week or longer;
• b. regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
• c. at least partial relief of breakthrough pain by use of opioid therapy;
• d. 20 years of age or older;
• e. ability to understand and willingness to sign a written informed consent document;
• f. able to self-administer the study medication correctly or has the availability of a responsible adult caregiver available to administer the study medication correctly;
• g. willing and able to complete patient diary with each pain episode

You may not qualify if:

• a. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
• b. history of hypersensitivity or intolerance to fentanyl;
• c. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
• d. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
• e. moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
• f. abnormal oral mucosa which will impede drug absorption;
• g. currently under other treatments that may alter effect of pain control based on investigator's judgment;
• h. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
• i. use of an investigational drug within 4 weeks preceding this study;
• j. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential;

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• TTY Biopharm: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, Taiwan

Location

Related Publications (5)

• Greco MT, Corli O, Montanari M, Deandrea S, Zagonel V, Apolone G; Writing Protocol Committee; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Epidemiology and pattern of care of breakthrough cancer pain in a longitudinal sample of cancer patients: results from the Cancer Pain Outcome Research Study Group. Clin J Pain. 2011 Jan;27(1):9-18. doi: 10.1097/AJP.0b013e3181edc250.

  PMID: 20842024 BACKGROUND

• Rhiner MI, von Gunten CF. Cancer breakthrough pain in the presence of cancer-related chronic pain: fact versus perceptions of health-care providers and patients. J Support Oncol. 2010 Nov-Dec;8(6):232-8. doi: 10.1016/j.suponc.2010.10.006.

  PMID: 21265388 BACKGROUND

• Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6.

  PMID: 21215653 BACKGROUND

• Rauck R, North J, Gever LN, Tagarro I, Finn AL. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol. 2010 Jun;21(6):1308-1314. doi: 10.1093/annonc/mdp541. Epub 2009 Nov 25.

  PMID: 19940014 BACKGROUND

• Chiou TJ, Chao TC, Chao TY, Huang JS, Chang YF, Wang CH. A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. Cancer Rep (Hoboken). 2019 Oct;2(5):e1179. doi: 10.1002/cnr2.1179. Epub 2019 Apr 23.

  PMID: 32721110 DERIVED

Study Officials

• Cheng-Hsu Wang

  Chang Gung Memorial Hospital, Linkou, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 13, 2018
• Study Start: November 25, 2014
• Primary Completion: June 23, 2016
• Study Completion: July 1, 2016
• Last Updated: September 13, 2018

Record last verified: 2018-08

Locations

TW (1)