Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
128
Countries
1
Sites
1
perioperative anxiety
Key facts
- Sponsor
- CHRU De Nancy
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 25 Apr 2018 → 5 Mar 2026
- Decision date (initial)
- 2024-07-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513816-86-00
- EudraCT number
- 2017-002112-13
- ClinicalTrials.gov
- NCT03327506
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
perioperative anxiety
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHRU De Nancy
- Sponsor organisation
- CHRU De Nancy
- Address
- Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034
- City
- Nancy Cedex
- Postcode
- 54035
- Country
- France
Scientific contact point
- Organisation
- CHRU De Nancy
- Contact name
- VIAL Florence
Public contact point
- Organisation
- CHRU De Nancy
- Contact name
- VIAL Florence
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 128 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
CHRU De Nancy
Gynecology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
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 |
|---|---|---|---|---|---|
| France | 2018-04-25 | 2026-03-05 | 2018-11-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | France | Acceptable 2024-07-25
|
2024-07-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-17 | France | Acceptable | 2025-11-04 |