Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Overactive bladder
Key facts
- Sponsor
- LiGalli B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 6 Feb 2024 → 27 Aug 2024
- Decision date (initial)
- 2024-02-05
- 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
Overactive bladder
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
LiGalli B.V.
- Sponsor organisation
- LiGalli B.V.
- Address
- J.h. Oortweg 21
- City
- Leiden
- Postcode
- 2333 CH
- Country
- Netherlands
Scientific contact point
- Organisation
- LiGalli B.V.
- Contact name
- Maaike Addicks
Public contact point
- Organisation
- LiGalli B.V.
- Contact name
- Maaike Addicks
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Internal Medicine, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-02-06 | 2024-08-27 | 2024-02-26 | 2024-08-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-20 | Netherlands | Acceptable 2024-02-02
|
2024-02-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-29 | Netherlands | Acceptable 2024-02-02
|
2024-03-29 |