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

Information source: Salvat
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Otomycosis

Intervention: G238 (Drug); Clotrimazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Salvat

Summary

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

Clinical Details

Official title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group, Active Treatment-controlled Study Assessing the Safety and Efficacy of G238 Compared to Clotrimazole 1% Otic Solution in Patients With Otomycosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical and mycological evaluation

Secondary outcome: Changes in signs/ symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years or older.

- Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion Criteria:

- Other ear diseases.

Locations and Contacts

Laboratorios SALVAT, S.A., Esplugues de Llobregat, Barcelona 08950, Spain
Additional Information

Starting date: May 2013
Last updated: April 15, 2015

Page last updated: August 23, 2015

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