Overview
Sponsor-declared trial summary
Intramuscular administration of triamcinolone acetonide Lisapharma (Injectable suspension of triamcinolone acetonide) is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndrome (to control severe or debilitating conditions not treatable in a conventional way), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases.
Key facts
- Sponsor
- Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 9 May 2024 → 27 Mar 2025
- Decision date (initial)
- 2024-04-04
- 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
Intramuscular administration of triamcinolone acetonide Lisapharma (Injectable suspension of triamcinolone acetonide) is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndrome (to control severe or debilitating conditions not treatable in a conventional way), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Sponsor organisation
- Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Address
- Via Licinio 11
- City
- Erba
- Postcode
- 22036
- Country
- Italy
Scientific contact point
- Organisation
- Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Contact name
- Matteo Farina
Public contact point
- Organisation
- Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
- Contact name
- Matteo Farina
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Italy | 2024-05-09 | 2025-03-27 | 2024-05-15 | 2024-06-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-28 | Italy | Acceptable 2024-04-02
|
2024-04-04 |