Otomycosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
Interventions
DRUGG238
Five drops into the ear canal twice daily for 14 days
DRUGClotrimazole
Five drops into the ear canal twice daily for 14 days
Sponsors
Salvat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Clinical diagnosis of otomycosis where topical treatment is indicated.
Exclusion criteria
* Other ear diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With a Complete Response to Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Signs/ Symptoms | 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. |
Other
| Measure | Time frame |
|---|---|
| Mycological Study | Day 24 |
Countries
Spain
Participant flow
Recruitment details
ENT Mexican sites
Participants by arm
| Arm | Count |
|---|---|
| G238 Five drops into the ear canal twice daily for 14 days
G238: Five drops into the ear canal twice daily for 14 days | 89 |
| Clotrimazole Five drops into the ear canal twice daily for 14 days
Clotrimazole: Five drops into the ear canal twice daily for 14 days | 85 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Requested by the patient | 6 | 11 |
Baseline characteristics
| Characteristic | G238 | Clotrimazole | Total |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 15.8 | 39.8 years STANDARD_DEVIATION 13 | 40.8 years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 44 Participants | 46 Participants | 90 Participants |
| Sex: Female, Male Male | 45 Participants | 39 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 85 |
| serious Total, serious adverse events | 0 / 89 | 0 / 85 |
Outcome results
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: * 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.
Time frame: Day 24
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| G238 | Proportion of Subjects With a Complete Response to Treatment | Complete Response | 72 participants |
| G238 | Proportion of Subjects With a Complete Response to Treatment | Partial Response | 11 participants |
| G238 | Proportion of Subjects With a Complete Response to Treatment | No-response | 5 participants |
| G238 | Proportion of Subjects With a Complete Response to Treatment | Missing data | 1 participants |
| Clotrimazole | Proportion of Subjects With a Complete Response to Treatment | Missing data | 6 participants |
| Clotrimazole | Proportion of Subjects With a Complete Response to Treatment | Complete Response | 66 participants |
| Clotrimazole | Proportion of Subjects With a Complete Response to Treatment | No-response | 2 participants |
| Clotrimazole | Proportion of Subjects With a Complete Response to Treatment | Partial Response | 11 participants |
Secondary
Changes in Signs/ Symptoms
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.
Time frame: 2 weeks and 4 weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| G238 | Changes in Signs/ Symptoms | Signs and symptoms score 0 at Day 15 | 59.55 percentage of patient |
| G238 | Changes in Signs/ Symptoms | Signs and symptoms score 0 at Day 24 | 85.83 percentage of patient |
| G238 | Changes in Signs/ Symptoms | Mycological cure at Day 24 | 96.63 percentage of patient |
| Clotrimazole | Changes in Signs/ Symptoms | Signs and symptoms score 0 at Day 15 | 77.65 percentage of patient |
| Clotrimazole | Changes in Signs/ Symptoms | Signs and symptoms score 0 at Day 24 | 86.08 percentage of patient |
| Clotrimazole | Changes in Signs/ Symptoms | Mycological cure at Day 24 | 97.65 percentage of patient |
Other Pre-specified
Mycological Study
Time frame: Day 24