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

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

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

Study Overview

• Status: Completed
• Conditions: Otomycosis
• Intervention / Treatment: Drug: G238; Drug: Clotrimazole

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Laboratorios Salvat, S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Other ear diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G238; Five drops into the ear canal twice daily for 14 days	Drug: G238; Five drops into the ear canal twice daily for 14 days
Active Comparator: Clotrimazole; Five drops into the ear canal twice daily for 14 days	Drug: Clotrimazole; Five drops into the ear canal twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With a Complete Response to Treatment	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.	Day 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Signs/ Symptoms	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.	2 weeks and 4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Mycological Study	Day 24

Collaborators and Investigators

• Sponsor: Salvat

Publications and helpful links

General Publications

• Lee A, Tysome JR, Saeed SR. Topical azole treatments for otomycosis. Cochrane Database Syst Rev. 2021 May 25;5(5):CD009289. doi: 10.1002/14651858.CD009289.pub2.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otomycosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: G238OTIII/11IA01