Overview
Sponsor-declared trial summary
No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the prophylaxis and symptomatic therapy of nausea and vomiting of various etiologies, especially kinetosis.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Hermes Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 23 Oct 2023 → 13 Dec 2023
- Decision date (initial)
- 2023-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the prophylaxis and symptomatic therapy of nausea and vomiting of various etiologies, especially kinetosis.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10054924 | Prophylaxis against motion sickness | 100000004865 |
| 20.0 | PT | 10027990 | Motion sickness | 100000004854 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova; MD, PhD
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Sacha Arsova; MD, PhD
Hermes Pharma GmbH
- Sponsor organisation
- Hermes Pharma GmbH
- Address
- Georg-Kalb-Strasse 5, Grosshesselohe Grosshesselohe
- City
- Pullach I. Isartal
- Postcode
- 82049
- Country
- Germany
Public contact point
- Organisation
- Hermes Pharma GmbH
- Contact name
- Dr. Benjamin Schwenk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 14 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2023-10-23 | 2023-12-13 | 2023-10-23 | 2023-10-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-28 | Bulgaria | Acceptable 2023-08-28
|
2023-10-02 |