Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
112
Countries
1
Sites
1
Treatment of pain
Key facts
- Sponsor
- Gruenenthal GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 5 Aug 2024 → 25 Feb 2026
- Decision date (initial)
- 2024-07-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512510-17-00
- WHO UTN
- U1111-1307-3561
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gruenenthal GmbH
- Sponsor organisation
- Gruenenthal GmbH
- Address
- Zieglerstrasse 6
- City
- Aachen
- Postcode
- 52078
- Country
- Germany
Scientific contact point
- Organisation
- Gruenenthal GmbH
- Contact name
- Grünenthal Trial Information Desk
Public contact point
- Organisation
- Gruenenthal GmbH
- Contact name
- Grünenthal Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 112 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-08-05 | 2026-02-25 | 2024-08-05 | 2026-01-26 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | Germany | Acceptable 2024-07-09
|
2024-07-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-27 | Germany | Acceptable 2024-07-09
|
2024-09-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-21 | Germany | Acceptable 2024-07-09
|
2025-05-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-27 | Germany | Acceptable 2025-10-20
|
2025-10-20 |