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

NCT01993823 | Completed Phase 3 Results

• 1 other identifier: G238OTIII/11IA01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Otomycosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Signs/ Symptoms

  2 weeks and 4 weeks

Other Outcomes (1)

• Mycological Study

  Day 24

Study Arms (2)

G238

EXPERIMENTAL

Five drops into the ear canal twice daily for 14 days

Drug: G238

Clotrimazole

ACTIVE COMPARATOR

Five drops into the ear canal twice daily for 14 days

Drug: Clotrimazole

Interventions

G238 DRUG

Five drops into the ear canal twice daily for 14 days

G238

Clotrimazole DRUG

Five drops into the ear canal twice daily for 14 days

Clotrimazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other ear diseases.

Sponsors & Collaborators

• Salvat: lead

Study Sites (1)

Laboratorios SALVAT, S.A.

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

• 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.

  PMID: 34033120 DERIVED

MeSH Terms

Conditions

Otomycosis

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Enrique Jimenez, Medical Director
• Organization: Laboratorios SALVAT

ejimenezv@salvatbiotech.com

+39933946470

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 4, 2017
• Results First Posted: February 13, 2017

Record last verified: 2017-03

Locations

ES (1)