Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
27
Countries
1
Sites
1
Irritable bowel syndrome
Key facts
- Sponsor
- Polyclinique De L'europe
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-02-08
- 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
Irritable bowel syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10023003 | Irritable bowel syndrome | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Polyclinique De L'europe
- Sponsor organisation
- Polyclinique De L'europe
- Address
- 33 Boulevard De L Universite
- City
- Saint-Nazaire
- Postcode
- 44600
- Country
- France
Scientific contact point
- Organisation
- Polyclinique De L'europe
- Contact name
- Principal investigator
Public contact point
- Organisation
- Polyclinique De L'europe
- Contact name
- general director of Polyclinique de l'Europe
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 27 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Polyclinique De L'europe
algologie, 33 Boulevard De L Universite, 44600, Saint-Nazaire
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-09 | France | Acceptable 2024-02-06
|
2024-02-08 |