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

Otomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993823
• Other study ID #: G238OTIII/11IA01
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2013
• Last updated: April 15, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Salvat
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older.

• Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion Criteria:

• Other ear diseases.

Study Design

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

Related Conditions & MeSH terms

• Otomycosis

Intervention

Drug:
• G238
Five drops into the ear canal twice daily for 14 days
• Clotrimazole
Five drops into the ear canal twice daily for 14 days

Locations

Country	Name	City	State
Spain	Laboratorios SALVAT, S.A.	Esplugues de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mycological study		Day 24	No
Primary	Clinical and mycological evaluation	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.	Day 24	No
Secondary	Changes in signs/ symptoms	The secondary efficacy variables will include: Proportion of subjects with signs and symptoms score of "0" at each visit.; Proportion of subjects with a negative culture for fungus or presumed eradication on Day 24.; The changes in signs and symptoms after two (2) weeks of treatment.; The changes in signs/symptoms at Day 24.; The mycological study results obtained in the cultures at day 24.; The number of patients with clinical cure or improvement at day 14 and 24.	2 weeks and 4 weeks	No