Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
chronic intestinal pseudo-obstruction (CIPO)
Key facts
- Sponsor
- Alfasigma S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 7 Oct 2024 → 21 Feb 2025
- Decision date (initial)
- 2024-09-10
- 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
chronic intestinal pseudo-obstruction (CIPO)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088266 | Chronic intestinal pseudo-obstruction | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alfasigma S.p.A.
- Sponsor organisation
- Alfasigma S.p.A.
- Address
- Via Ragazzi Del '99 5
- City
- Bologna
- Postcode
- 40133
- Country
- Italy
Scientific contact point
- Organisation
- Alfasigma S.p.A.
- Contact name
- Paolo Battigello
Public contact point
- Organisation
- Alfasigma S.p.A.
- Contact name
- Paolo Battigello
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2024-10-07 | 2025-02-21 | 2024-10-07 | 2025-01-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-29 | Netherlands | Acceptable 2024-09-10
|
2024-09-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-12 | Netherlands | Acceptable 2024-09-10
|
2024-12-12 |