Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
75
Countries
1
Sites
1
Anesthesia and Analgesia, patient safety
Key facts
- Sponsor
- University Of Debrecen
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 18 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Anesthesia and Analgesia, patient safety
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Debrecen
- Sponsor organisation
- University Of Debrecen
- Address
- Nagyerdei Korut 98
- City
- Debrecen
- Postcode
- 4032
- Country
- Hungary
Scientific contact point
- Organisation
- University Of Debrecen
- Contact name
- Végh Tamas M.D.
Public contact point
- Organisation
- University Of Debrecen
- Contact name
- Végh Tamas M.D.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruiting | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2024-06-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | Hungary | Acceptable 2024-06-05
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | Hungary | Acceptable 2024-06-18
|
2024-06-18 |