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Completed

NCT Number: NCT01993823

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

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

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Key information

Conditions

Otomycosis Bacterial Infections and Mycoses Ear Diseases Infections Mycoses Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratorios SALVAT, S.A.

Esplugues de Llobregat, Barcelona, 08950, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other ear diseases.

Treatment and study plan

G238

Drug

Five drops into the ear canal twice daily for 14 days

clotrimazole

Drug

Five drops into the ear canal twice daily for 14 days

Primary outcomes

  1. Proportion of Subjects With a Complete Response to Treatment

    Time frame: 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 outcomes

  1. Changes in Signs/ Symptoms

    Time frame: 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.

Other outcomes

  1. Mycological Study

    Time frame: Day 24

Sponsors and collaborators

Lead sponsor

Salvat

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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