Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
188
Countries
1
Sites
6
Subject with chronic coccygodynia
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 8 Nov 2023 → ongoing
- Decision date (initial)
- 2023-08-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504644-34-00
- ClinicalTrials.gov
- NCT06023706
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Subject with chronic coccygodynia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10054095 | Neuropathic pain | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- LEVESQUE Amélie
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- LEVESQUE Amélie
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 188 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Departmental Hospital Vendee
Algology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Algology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre Hospitalier Universitaire De Nantes
Algology, 1 Place Alexis Ricordeau, 44000, Nantes
CHU De Rouen
Algology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Algology, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
L'Hopital Prive Du Confluent
Algology, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
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 | 2023-11-08 | 2023-11-08 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-04 | France | Acceptable 2023-08-08
|
2023-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-08 | France | Acceptable | 2023-10-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-19 | France | Acceptable | 2023-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-22 | France | Acceptable 2024-07-22
|
2024-07-25 |