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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Wi

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

Detailed Summary:
Sponsor: Salvat

Current Primary Outcome: 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.


Original Primary Outcome: Clinical and Mycological Evaluation [ 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: Changes in Signs/ Symptoms [ Time Frame: 2 weeks and 4 weeks ]

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.


Information By: Salvat

Dates:
Date Received: October 9, 2013
Date Started: May 2013
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017