Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
50
Countries
1
Sites
1
PAIN MANAGEMENT
Questionary to Fentanyl Nasal Spray Efficiancy and Safety
Key facts
- Sponsor
- Semmelweis University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2025-10-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Semmelweis University
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Questionary to Fentanyl Nasal Spray Efficiancy and Safety
Conditions and MedDRA coding
PAIN MANAGEMENT
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519131-42-00 | F-puff_SE_2024 | Semmelweis University |
| 2024-519131-42-01 | F-puff_SE_2024 | Semmelweis University |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- OVER 18 YEARS CANCER PATIENTS UNDER PAIN THERAPY
- 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).
- major opioid therapy
- clear state of mind
- they can use the nasal spray by themselfes
- not pregnant, not breastfeeding
- no cancerous tumour in mouth or nose
- breath count above 10/min
- no known fentanyl allergy
Exclusion criteria 4
- YOUNGER THAN 18 YEARS OLD
- no malignacy
- Week lung capacity where assisted respiration is not needed (due to the respiration depressant effect of drugs with morphymomethic nature)
- Hypersensitivity to fentanyl or to any opioids.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- responder rate (on NPRS scale)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Fentanyl Kalceks 50 mikrogramm/ml oldatos injekció
PRD8243269 · Product
- Active substance
- Fentanyl
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 98 µg microgram(s)
- Max total dose
- 17600 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- OGYI-T-23704/01
- MA holder
- KALCEKS
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Use in nasal spray
Fentanyl Sandoz 50 mikrogramm/ml oldatos injekció
PRD8156738 · Product
- Active substance
- Fentanyl Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 98 µg microgram(s)
- Max total dose
- 17800 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- OGYI-T-23686/02
- MA holder
- SANDOZ HUNGÁRIA KFT
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Use in nasal spray
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Semmelweis University
- Sponsor organisation
- Semmelweis University
- Address
- Szentkiralyi Utca 46, VIII Kerulet VIII Kerulet
- City
- Budapest VIII
- Postcode
- 1088
- Country
- Hungary
Scientific contact point
- Organisation
- Semmelweis University
- Contact name
- Horvath Bohus Anna
Public contact point
- Organisation
- Semmelweis University
- Contact name
- Horvath Bohus Anna
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519131-42-02 | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults_v2 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS adults_v2 | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Information leaflet adult | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC F-puff | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fentanyl Kalceks | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fentanyl Sandoz | 1 |
| Synopsis of the protocol (for publication) | D1_Protokoll szinopszis HU 2024-519131-42-02 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-07 | Hungary | Acceptable 2025-10-07
|
2025-10-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-09 | Hungary | Acceptable 2025-10-07
|
2025-12-09 |