Trial · NCT01993823
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
NCT01993823, Phase 3, Completed, Salvat; results first posted 2017-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis. Trials, record NCT01993823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01993823
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
- NCT number
- NCT01993823
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 190 participants, actual
- Lead sponsor
- Salvat
- Conditions
- Otomycosis
- Interventions
- G238, Clotrimazole
- First posted
- 2013-11-25
- Last updated
- 2017-04-04
- Results first posted
- 2017-02-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | Mycological Study | Day 24 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects With a Complete Response to Treatment | Day 24 | ITT | participants | NUMBER |
| SECONDARY | Changes in Signs/ Symptoms | 2 weeks and 4 weeks | ITT | percentage of patient | NUMBER |
| OTHER_PRE_SPECIFIED | Mycological Study | Day 24 |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects With a Complete Response to Treatment | G238 | Complete Response | 72 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | Clotrimazole | Complete Response | 66 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | G238 | Partial Response | 11 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | Clotrimazole | Partial Response | 11 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | G238 | No-response | 5 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | Clotrimazole | No-response | 2 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | G238 | Missing data | 1 | participants | |
| Proportion of Subjects With a Complete Response to Treatment | Clotrimazole | Missing data | 6 | participants | |
| Changes in Signs/ Symptoms | G238 | Signs and symptoms score 0 at Day 15 | 59.55 | percentage of patient | |
| Changes in Signs/ Symptoms | Clotrimazole | Signs and symptoms score 0 at Day 15 | 77.65 | percentage of patient |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | G238 | 95 | |
| Overall Study | STARTED | Clotrimazole | 95 | |
| Overall Study | COMPLETED | G238 | 88 | |
| Overall Study | COMPLETED | Clotrimazole | 79 | |
| Overall Study | NOT COMPLETED | G238 | 7 | |
| Overall Study | NOT COMPLETED | Clotrimazole | 16 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G238 | ||
| Total, all-cause mortality | Clotrimazole | ||
| Total, other adverse events | G238 | 0 | 89 |
| Total, other adverse events | Clotrimazole | 0 | 85 |
| Total, serious adverse events | G238 | 0 | 89 |
| Total, serious adverse events | Clotrimazole | 0 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34033120 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| G238 vs Clotrimazole: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01993823
GET https://conductscience.org/api/trials/v1/NCT01993823/registered