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

Phase 3

Completed

• Conditions: Otomycosis
• Interventions: Drug: G238; Drug: Clotrimazole

• Registration Number: NCT01993823
• Lead Sponsor: Salvat

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-12-21
• Results First Submitted QC: 2016-12-21
• Results First Posted: 2017-02-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

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

Exclusion Criteria

• Other ear diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G238	G238	Five drops into the ear canal twice daily for 14 days
Clotrimazole	Clotrimazole	Five drops into the ear canal twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With a Complete Response to Treatment	Day 24	Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24.; Response to the study treatment was classed according to the following definitions: * Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24.; * Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24.; * No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms \> 2 on day 24.

Secondary Outcome Measures

Name	Time	Method
Changes in Signs/ Symptoms	2 weeks and 4 weeks	The secondary efficacy variables include: * Proportion of subjects with signs and symptoms score of "0" at Day 15; * Proportion of subjects with signs and symptoms score of "0" at Day 24; * Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24.

Trial Locations

Locations (1)

Laboratorios SALVAT, S.A.; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain