Clinical trial • Phase III • Other

FENTANYL for Breakthrough cancer pain | Cancer-related pain

Phase III trial of FENTANYL for Breakthrough cancer pain | Cancer-related pain. 50 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Breakthrough cancer pain | Cancer-related pain
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-08-2025
First CTIS Authorization Date
22-10-2025

Trial design

Phase III trial across 1 site in Hungary.

Target Sample Size
50

Eligibility

Recruits 50 isVulnerablePopulationSelected=false; no additional vulnerable population or consent/assent handling specified in the record.

Pregnancy Exclusion
not pregnant, not breastfeeding
Vulnerable Population
isVulnerablePopulationSelected=false; no additional vulnerable population or consent/assent handling specified in the record

Inclusion criteria

  • {"criterion_text":"- OVER 18 YEARS CANCER PATIENTS UNDER PAIN THERAPY"}
  • {"criterion_text":"- We consider the study to be professionally based only among patients who are treated with F-puff according to the simplified off label recommendation, under routine treatment. Please amend the inclusion criteria with the following: - Patients with severe cancer, where beyond the standard pain relief therapy, severe, acute pain (breakthrough pain) occurs, and who were diagnosed with cancer according to the simplified off label access recommendation by HU NCA (NNGYK) (case number: NNGYK/GYSZ/40594-2/2024)."}
  • {"criterion_text":"- major opioid therapy"}
  • {"criterion_text":"- clear state of mind"}
  • {"criterion_text":"- they can use the nasal spray by themselfes"}
  • {"criterion_text":"- not pregnant, not breastfeeding"}
  • {"criterion_text":"- no cancerous tumour in mouth or nose"}
  • {"criterion_text":"- breath count above 10/min"}
  • {"criterion_text":"- no known fentanyl allergy"}

Exclusion criteria

  • {"criterion_text":"- YOUNGER THAN 18 YEARS OLD"}
  • {"criterion_text":"- no malignacy"}
  • {"criterion_text":"- Week lung capacity where assisted respiration is not needed (due to the respiration depressant effect of drugs with morphymomethic nature)"}
  • {"criterion_text":"- Hypersensitivity to fentanyl or to any opioids."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- responder rate (on NPRS scale)","definition_or_measurement_approach":"Responder rate measured on NPRS scale (on NPRS scale)"}

Recruitment

Planned Sample Size
50
Recruitment Window Months
19
Consent Approach
Informed consent obtained from adult participants; subject information sheet and informed consent form available for adults (documents: L1_SIS adults, L1_ICF adults); trial excludes participants younger than 18; study materials/translations available in Hungarian.

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Hungary

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
37
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Contact Person Name
Anna Horvath Bohus
Number Of Participants
50

Sponsor

Primary sponsor

Full Name
Semmelweis University
Organisation Type
Educational Institution
Country Of Registered Address
Hungary

Investigational products

Investigational Product Name
Fentanyl Kalceks 50 mikrogramm/ml oldatos injekció
Active Substance
FENTANYL
Modality
Small molecule
Routes Of Administration
NASAL SPRAY
Route
NASAL SPRAY
Authorisation Status
Authorised (marketing authorisation present; authorisationCountryCode: HU)
Maximum Dose
98 µg per day
Investigational Product Name
Fentanyl Sandoz 50 mikrogramm/ml oldatos injekció
Active Substance
FENTANYL CITRATE
Modality
Small molecule
Routes Of Administration
NASAL SPRAY
Route
NASAL SPRAY
Authorisation Status
Authorised (marketing authorisation present; authorisationCountryCode: HU)
Maximum Dose
98 µg per day

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