WHO ICTRP trial
Clinical Trial to Assess the Efficacy and Safety of Clotrimazole 1% Otic…
EUCTR2019-003463-22-PT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-003463-22-PT |
|---|---|
| Public title | Clinical Trial to Assess the Efficacy and Safety of Clotrimazole 1% Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis). |
| Scientific title | A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Clotrimazole 1% Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis). - CLEAR 2 |
| Primary sponsor | Laboratorios Salvat, S.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;Spain;Romania;Bulgaria |
| Conditions | Fungal Otitis Externa (Otomycosis) MedDRA version: 20.0 Level: PT Classification code 10052557 Term: Otitis externa fungal System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and… |
| Interventions | Product Name: Clotrimazole Product Code: Clotrimazole 1% Otic Solution Pharmaceutical Form: Ear drops, solution INN or Proposed INN: Clotrimazole CAS Number: 23593-75-1 Other descriptive name: CLOTRIMAZOLE Concentration unit: mg… |
| Registration date | Jan 16, 2020 |
| Target size | 191 |
| Secondary IDs | CLOTOT3-16IA03;NCT03686397 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: