Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
1
Post-operative recovery after hip fracture surgery in frail elderly patients.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Not possible to specify
- Decision date (initial)
- 2025-05-05
- 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
Post-operative recovery after hip fracture surgery in frail elderly patients.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Margareta Hedström
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Margareta Hedström
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Sweden | Acceptable with conditions 2025-04-29
|
2025-05-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-28 | Sweden | Acceptable with conditions | 2025-08-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Sweden | Acceptable with conditions | 2025-07-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-15 | Sweden | Acceptable 2026-01-29
|
2026-01-30 |