Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

Salvat

Status and phase: Completed; Phase 3

Conditions: Otomycosis

Treatments: Drug: Clotrimazole; Drug: G238

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993823

G238OTIII/11IA01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older.
• Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion criteria

• Other ear diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

190 participants in 2 patient groups

G238

Experimental group

Description:

Five drops into the ear canal twice daily for 14 days

Treatment:

Drug: G238

Clotrimazole

Active Comparator group

Description:

Five drops into the ear canal twice daily for 14 days

Treatment:

Drug: Clotrimazole