Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
1
Eosinophilic Esophagitis as a archetype of chronic inflammatory digestive disease
Key facts
- Sponsor
- Hospital General De Tomelloso
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520751-83-00
- EudraCT number
- 2019-004206-94
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Eosinophilic Esophagitis as a archetype of chronic inflammatory digestive disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital General De Tomelloso
- Sponsor organisation
- Hospital General De Tomelloso
- Address
- Vereda De Socuellamos S/n
- City
- Tomelloso
- Postcode
- 13700
- Country
- Spain
Scientific contact point
- Organisation
- Hospital General De Tomelloso
- Contact name
- Sponsor & Principal Investigator
Public contact point
- Organisation
- Hospital General De Tomelloso
- Contact name
- Sponsor & Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-23 | Spain | Acceptable with conditions 2025-01-28
|
2025-01-28 |