Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
276
Countries
1
Sites
7
Achilles tendinopathy
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2026-03-16
- 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
Achilles tendinopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10050471 | Achilles tendon pain | 10028395 |
| 27.0 | LLT | 10000433 | Achilles tendinitis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Robert-Jan de Vos
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Kristel van Abswoude
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 276 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Orthopedics and Sports Medicine, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
Ziekenhuis Gelderse Vallei Stichting
Sports Medicine, Willy Brandtlaan 10, 6716 RP, Ede Gld
Bergman Clinics Nederland B.V.
Sports Medicine, Gooimeer 11, 1411 DE, Naarden
Haaglanden Medisch Centrum Stichting
Sports Medicine, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Umcu
Sports Medicine, Heidelberglaan 100, 3584 CX, Utrecht
Isala Klinieken Stichting
Sports Medicine, Dokter Van Heesweg 2, 8025 AB, Zwolle
Amsterdam UMC Stichting
Orthopedics and Sports Medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-24 | Netherlands | Acceptable 2026-03-16
|
2026-03-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Netherlands | Acceptable 2026-03-16
|
2026-05-28 |