Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
70
Countries
1
Sites
1
Osteoarthritis of the Hip
Key facts
- Sponsor
- Martina Hansens Hospital AS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2025-05-15
- 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
Osteoarthritis of the Hip
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Martina Hansens Hospital AS
- Sponsor organisation
- Martina Hansens Hospital AS
- Address
- Doenskiveien 8
- City
- Gjettum
- Postcode
- 1346
- Country
- Norway
Scientific contact point
- Organisation
- Martina Hansens Hospital AS
- Contact name
- Stig Heir
Public contact point
- Organisation
- Martina Hansens Hospital AS
- Contact name
- Stig Heir
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 70 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-28 | Norway | Acceptable with conditions 2025-05-06
|
2025-05-15 |