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

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ClinicalTrials.gov Identifier: NCT01993823
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : February 13, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Salvat

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis

Condition or disease Intervention/treatment Phase
Otomycosis Drug: G238 Drug: Clotrimazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Mycological Study [ Time Frame: Day 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other ear diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993823


Locations
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Spain
Laboratorios SALVAT, S.A.
Esplugues de Llobregat, Barcelona, Spain, 08950
Sponsors and Collaborators
Salvat
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01993823    
Other Study ID Numbers: G238OTIII/11IA01
First Posted: November 25, 2013    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Otomycosis
Mycoses
Bacterial Infections and Mycoses
Infections
Ear Diseases
Otorhinolaryngologic Diseases
Clotrimazole
Miconazole
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal Agents
 14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors