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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Proportion of Subjects With a Complete Response to Treatment
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older.
- •Clinical diagnosis of otomycosis where topical treatment is indicated.
Exclusion Criteria
- •Other ear diseases.
Arms & Interventions
G238
Five drops into the ear canal twice daily for 14 days
Intervention: G238 (Drug)
Clotrimazole
Five drops into the ear canal twice daily for 14 days
Intervention: Clotrimazole (Drug)
Outcomes
Primary Outcomes
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
- Changes in Signs/ Symptoms(2 weeks and 4 weeks)