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The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G238 | Experimental | Five drops into the ear canal twice daily for 14 days |
|
| Clotrimazole | Active Comparator | Five drops into the ear canal twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G238 | Drug | Five drops into the ear canal twice daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Signs/ Symptoms | The secondary efficacy variables include:
| 2 weeks and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological Study | Day 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios SALVAT, S.A. | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033120 | Derived | 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. |
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ENT Mexican sites
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| ID | Title | Description |
|---|---|---|
| FG000 | G238 | Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days |
| FG001 | Clotrimazole | Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population: Randomized patients who had at least one efficacy evaluation after starting treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | G238 | Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days |
| BG001 | Clotrimazole | Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| ITT | Posted | Number | participants | Day 24 |
|
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The safety analysis was conducted on the safety population (SAF), i.e. the population that includes all the randomised subjects who took at least one dose of the trial drug and had a safety evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G238 | Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Jimenez, Medical Director | Laboratorios SALVAT | +39933946470 | ejimenezv@salvatbiotech.com |
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| ID | Term |
|---|---|
| D059249 | Otomycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004427 | Ear Diseases |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clotrimazole |
| Drug |
Five drops into the ear canal twice daily for 14 days |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days |
| OG001 | Clotrimazole | Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days |
|
|
| Secondary | Changes in Signs/ Symptoms | The secondary efficacy variables include:
| ITT | Posted | Number | percentage of patient | 2 weeks and 4 weeks |
|
|
|
| Other Pre-specified | Mycological Study | Not Posted | Day 24 | Participants |
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Clotrimazole | Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days | 0 | 85 | 0 | 85 |
Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
| D010038 |
| Otorhinolaryngologic Diseases |
| Mycological cure at Day 24 |
|