Phase 3
N=190
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
Otomycosis
Bottom Line
View on ClinicalTrials.gov: NCT01993823 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Proportion of Subjects With a Complete Response to Treatment — 72; 66; 11; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- G238 (Drug); Clotrimazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Salvat
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With a Complete Response to Treatment |
72; 66; 11; 11; 5; 2 | — |
| SECONDARY Changes in Signs/ Symptoms |
59.55; 77.65; 85.83; 86.08; 96.63; 97.65 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Clinical diagnosis of otomycosis where topical treatment is indicated.
Exclusion Criteria
- Other ear diseases.
Data sourced from ClinicalTrials.gov (NCT01993823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.