This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis (NCT01993823), a randomized phase 3 study. The primary outcome is Proportion of Subjects With a Complete Response to Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01993823 |
| Phase | Phase 3 |
| Condition | Otomycosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 190 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Salvat |
| Results posted | Yes |
2. Clinical Question
Population
Participants with otomycosis were enrolled. The primary outcome is labeled as using the ITT population, although the registry record does not report further details about that analysis population or how participants were handled in the analysis.
Intervention
G238 was given as five drops into the ear canal twice daily for 14 days.
Comparator
The active comparator was clotrimazole 1% otic solution. Its arm description specifies five drops into the ear canal twice daily for 14 days.
Primary question
The primary question was the proportion of participants with a complete response on Day 24. The registry defines this response using fungal culture status or presumed eradication together with a signs-and-symptoms score of 0. It does not report the response proportion for either group or a statistical comparison between them.
This is an active-treatment comparison, not a comparison with no treatment or placebo. Its central statistical question is whether the groups differed in the proportion meeting the specified Day 24 response definition. That question requires the group-specific outcome counts, a clearly described analysis, and an estimate of the between-group difference with its uncertainty. Those results are not reported in the registry record, so the direction and precision of any difference cannot be described from this record.
3. Trial Design
The registry describes a Phase III, multicenter, randomized, double-blind, parallel-group study with active treatment control. The study was completed. Its listed enrollment is 190 participants. The registry record identifies otomycosis as the condition and Salvat as the sponsor.
Participants were assigned to G238 or clotrimazole. Both arm descriptions specify five drops into the ear canal twice daily for 14 days; the official study title identifies the comparator as clotrimazole 1% otic solution. Randomization is intended to make treatment groups comparable on average at the point of assignment. Double blinding is intended to reduce the influence of treatment knowledge on participant experience, care, assessment, and reporting, although the registry record does not describe how masking was maintained or assessed. A parallel-group design means participants were assigned to a treatment group rather than described as switching between treatments.
The registry lists a start date of 2013-05 and primary completion date of 2014-11. These record dates describe the study timeline, not the duration of treatment for an individual participant; the arm descriptions separately state the treatment period. The primary endpoint assessment was scheduled for Day 24.
The record identifies the primary outcome as the proportion of subjects with a complete response to treatment and labels its population ITT. It also lists changes in signs and symptoms among the secondary outcomes and three outcome measures overall, but does not provide further outcome results in the record excerpt. A total of 0 analyses is listed. The registry record does not report the randomization procedure, allocation concealment, detailed analysis plan, sample-size justification, or procedures for handling protocol deviations.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | G238 | Clotrimazole |
|---|---|---|
| STARTED | 95 | 95 |
| COMPLETED | 88 | 79 |
| NOT COMPLETED | 7 | 16 |
Reasons for not completing this period:
| Reason | G238 | Clotrimazole |
|---|---|---|
| Requested by the patient | 6 | 11 |
| Protocol Violation | 0 | 1 |
| Lost to Follow-up | 1 | 4 |
Analysis population for the primary outcome, as defined in the registry: ITT
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: ITT population: Randomized patients who had at least one efficacy evaluation after starting treatment
| Characteristic | Unit | G238 | Clotrimazole | Total |
|---|---|---|---|---|
| Participants analysed | 89 | 85 | 174 | |
| Age, Continuous | years | 41.8 (SD 15.8) | 39.8 (SD 13.0) | 40.8 (SD 14.5) |
| Sex: Female, Male: Female | Participants | 44 | 46 | 90 |
| Sex: Female, Male: Male | Participants | 45 | 39 | 84 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Subjects With a Complete Response to Treatment, measured over Day 24.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of participants with a complete response on Day 24. The registry describes assessment through fungal culture and the sum of scores for pruritus, otalgia, otorrhea, and aural fullness or obstruction. Each symptom is scored as absent, mild, moderate, or severe, using scores of 0, 1, 2, or 3, respectively. The primary efficacy variable is described as a negative fungal culture together with a signs-and-symptoms score of 0 on Day 24.
The response categories add detail: complete response is defined as a negative culture or presumed eradication on Day 24 and a symptom sum score of 0. Partial response is defined as a negative culture or presumed eradication and a score of 1 or 2. No response is defined as a positive culture, or a negative culture or presumed eradication with a score greater than 2. The primary-variable description and the complete-response category differ in their wording about presumed eradication; the registry record does not clarify that distinction.
A combined culture-and-symptom endpoint is used to classify response across both a microbiological measure and reported clinical signs or symptoms. As a proportion, it would express how many participants in each analysis group met the response definition. The registry record does not report those proportions, so the endpoint’s observed results cannot be interpreted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record establishes the study question and design but does not provide the data needed to answer the primary statistical question. Although the primary endpoint is defined for Day 24 and the analysis population is labeled ITT, neither the number of complete responders nor the corresponding group proportions are reported. The record also lists 0 analyses. Consequently, there is no reported treatment contrast, confidence interval, p-value, or other inferential result to interpret.
This absence matters because a trial’s design and its outcome findings are different kinds of information. Randomization and masking describe how the comparison was organized; they do not establish the outcome pattern. Enrollment of 190 describes the planned or recorded enrollment total, but does not reveal how many participants contributed endpoint data or met the response definition. The registry record does not report those details.
General: a proportion estimates the frequency of an outcome in a group. Comparing proportions can describe the size and direction of a group difference, while a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A p-value addresses compatibility between the observed data and a specified statistical null model; it does not convey the size or clinical importance of a difference by itself. None of these quantities can be reconstructed from the study design description alone.
The outcome itself has a combined definition. A participant must meet the culture and symptom criteria specified by the registry to be classified as a complete responder. The record’s wording varies between the primary-variable description and the response-category definition regarding presumed eradication. Without clarification and participant-level or group-level results, it is not possible to determine how that wording was implemented or how many participants qualified.
The registry’s reported safety counts are separate from the efficacy endpoint. They list 0 serious adverse events and 0 other adverse events for each arm among the stated at-risk groups. Those counts are descriptive registry entries; they do not supply an efficacy estimate or establish that no adverse events occurred beyond what was recorded. Death counts are not reported as values in the record.
Therefore, the defensible interpretation is limited: this record documents a randomized active-treatment study and defines a Day 24 response outcome, but does not report the primary outcome findings or statistical comparison. It cannot support a conclusion about the relative response proportions, their precision, or the statistical evidence for a difference. Those conclusions would require results not reported in the registry record.
9. Statistical Methods Explained
General: a randomized trial assigns participants to treatment groups by chance. If assignment is implemented as planned, randomization can reduce systematic differences between groups at the start of the comparison, including differences that were not measured. It does not guarantee that every characteristic is balanced in a particular study, and it does not replace reporting the outcome data and analysis. The registry identifies this study as randomized but does not report the specific randomization sequence method or allocation-concealment procedure.
General: blinding means that specified people are kept unaware of treatment assignment, which can help limit behavior or assessment being influenced by expectations. The record calls the study double-blind but does not identify which people were blinded, describe the masking procedures, or report whether blinding was maintained. The parallel-group description indicates assignment to a treatment arm for comparison, while the active-control design compares G238 with clotrimazole rather than with an untreated group.
The primary outcome is a binary response classification: each participant either meets the complete-response definition or does not. The corresponding group-level result would ordinarily be represented as a count and a proportion. A comparison could then be expressed as an absolute difference in proportions, a relative measure, or another prespecified contrast. The registry record reports none of these results. It does not report a model, an adjustment set, or a test for the primary endpoint, and the analysis count is 0.
General: a confidence interval gives a range of values that are compatible with the observed data and the method’s assumptions, and it communicates uncertainty in an estimate. Its width depends on factors including the amount of information in the data and the variability of the outcome. A p-value is a measure of how unusual data at least as discordant with a null hypothesis would be under that hypothesis and the chosen model. Neither quantity can be inferred from the fact that a study was randomized, from enrollment alone, or from safety counts. No confidence interval or p-value for efficacy is reported in the registry record.
The endpoint combines culture status with a score formed from pruritus, otalgia, otorrhea, and aural fullness or obstruction. Combining measures can make the outcome reflect more than one dimension of response, but it also makes the definition and its implementation important. The record gives scoring categories and response categories, but the primary-variable description and the complete-response category are not identical in their wording about negative culture or presumed eradication. The registry record does not explain how that wording was resolved for analysis.
The analysis population is labeled ITT. General: an intention-to-treat approach ordinarily analyzes participants according to their randomized assignment, irrespective of treatment received, but the label alone does not establish exactly how the analysis was performed. The registry record does not report the number analyzed in each group, exclusions, adherence to assigned treatment, or how missing Day 24 culture or symptom information was handled. It also does not report whether any additional populations were analyzed.
The registry lists three outcome measures and names changes in signs and symptoms as a secondary outcome. It does not describe the timing, scoring, or analysis of that secondary outcome beyond the information in the primary description. Multiple outcomes or repeated assessment times can raise multiplicity concerns: conducting several tests can increase the chance of a nominally unusual result when all null hypotheses are true. General statistical practice may address this through prespecification, adjustment, or a hierarchy of outcomes. The registry record does not report whether any such approach was planned or used, so no multiplicity adjustment can be assumed.
The sample-size assumptions describe a planning illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are stated as planning assumptions, not as the study’s own design justification. The record does not report the protocol’s sample-size calculation or its assumed treatment effect. Planning illustrations are not observed power: they do not show the probability that the completed trial detected an effect, and they are not outcome findings. No numerical illustration values or observed efficacy effect are reported in the registry record.
General: over-dispersion is extra variability beyond what a statistical model assumes. It matters when the chosen model’s variance assumptions do not match the data, because estimates of uncertainty and tests can then be misleading. The primary endpoint is a participant-level binary response, and the registry record does not report use of a model for which over-dispersion assessment is described. There is therefore no basis to say that over-dispersion was assessed or relevant to the sponsor’s analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists three outcome measures and identifies changes in signs and symptoms as a secondary outcome. It does not report a complete outcome-by-timepoint analysis plan, a hierarchy for testing outcomes, or any multiplicity adjustment. When several outcomes or time points are tested, multiplicity can make isolated nominal findings harder to interpret because the chance of at least one apparently unusual result can increase. General approaches include prespecifying a primary comparison, adjusting significance thresholds, or interpreting secondary analyses as exploratory. The registry record does not say which, if any, approach was used.
Missing-data methods are not reported in the registry record. The primary outcome requires culture and symptom information on Day 24, but the record does not state how unavailable cultures, incomplete symptom scores, withdrawals, or other missing endpoint information were handled. It also does not report the number of participants with evaluable endpoint data by arm. This limits assessment of how the ITT label was operationalized and whether missingness could affect the estimated response proportions.
The primary outcome is labeled ITT, but the record does not give a detailed definition of the analysis population, participant flow, protocol deviations, or analyses of other populations. The registry lists 0 analyses, so it does not provide an inferential analysis to evaluate. These omissions do not establish that no such procedures were used in the full study; they mean that the registry record does not report them.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| G238 | 0 | 89 | 0.0% |
| Clotrimazole | 0 | 85 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| G238 | 0 of 89 |
| Clotrimazole | 0 of 85 |
The registry lists 89 participants at risk for serious adverse events in the G238 group and 85 in the clotrimazole group. It records 0 serious adverse events in each group. For other adverse events, it lists 89 at risk with 0 events for G238 and 85 at risk with 0 events for clotrimazole. The serious-adverse-event term list is empty.
These are descriptive registry counts, not a comparative safety analysis. The record does not report definitions, collection procedures, follow-up completeness, event-level details, or statistical estimates for between-group differences. The death entries are null, so deaths are not reported in the registry record; a null entry should not be read as a reported count of zero.
General: a zero recorded count means no event was entered in that category for the stated at-risk group in the registry results. It does not establish that the underlying risk is zero, nor does it by itself show equivalence between treatments. Interpreting safety requires attention to how events were collected, the amount of follow-up, and uncertainty around event rates. Those details and uncertainty estimates are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that G238 was compared with clotrimazole in a randomized, double-blind, parallel-group study of otomycosis. It specifies the treatment regimens and defines complete response at Day 24 using culture status and a signs-and-symptoms score. It also records zero serious and zero other adverse events in the stated at-risk groups.
Those design and safety details do not answer whether one group had a greater proportion of complete responders. The registry record does not report the number of responders, group proportions, treatment contrast, confidence interval, or p-value. The analysis count is 0. As a result, the available record cannot establish the direction, magnitude, or precision of an efficacy difference.
General: a statistically significant result, if reported, would not by itself establish that an effect is clinically important. Conversely, a result that is not statistically significant would not establish that treatments are equivalent. Both interpretations require the estimate, uncertainty, the analysis plan, and relevant clinical context. None of those efficacy results are reported in this record.
The response definition also requires careful reading. The primary efficacy variable states a negative culture and a symptom score of 0, while the complete-response category describes a negative culture or presumed eradication alongside a score of 0. The registry record does not explain the difference in wording or how it was applied. This is a limitation in understanding the endpoint as implemented, separate from the absence of response results.
The safety entries should likewise be read narrowly as recorded counts. They do not establish the absence of all possible harms or provide a precise comparison of safety between groups. Overall, the record describes the intended comparison and selected registry entries, but it does not provide enough outcome information to draw a statistical conclusion about comparative efficacy or safety.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clear endpoint definition and complete results reporting are both necessary. Randomization, blinding, and an active comparator describe features intended to support a fair treatment comparison. But the statistical question depends on the observed outcomes: the numbers meeting the complete-response definition, their group denominators, and an analysis that quantifies the contrast and uncertainty. Those results are not reported in the registry record.
The endpoint combines fungal culture with a score based on symptoms. Such a composite classification can represent more than one aspect of an outcome, but readers need a consistent operational definition to understand what is counted as a response. Here, the registry’s primary-variable and complete-response descriptions differ in their wording about presumed eradication. Without clarification, even a reported response count would require care in interpreting how the definition was applied.
The record also illustrates the distinction between an analysis plan and a result. It states assumptions for a planning illustration, including a two-sided significance level of 0.05, equal allocation, and a normal approximation, but does not report the study’s own sample-size justification or a primary analysis. A planning illustration cannot substitute for observed results, and it is not evidence of observed power.
Finally, safety counts and efficacy findings answer different questions. The registry lists zero recorded adverse events in the stated categories, but does not report a detailed comparative safety analysis. Clear reporting of outcomes, missing-data handling, analysis populations, and uncertainty is needed to evaluate both benefit-related endpoints and harms. The record’s design details alone cannot supply those missing conclusions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this specific study is that the registry record does not report the primary outcome results. It gives no group-specific complete-response counts or proportions, treatment-effect estimate, confidence interval, or p-value. Without these, the primary comparison cannot be quantified or interpreted for direction and precision.
The endpoint definition has a wording ambiguity: the primary efficacy variable calls for negative culture and a score of 0, while the complete-response category allows negative culture or presumed eradication with a score of 0. The record does not explain how presumed eradication was determined or how the two descriptions were reconciled.
The registry labels the primary population ITT but does not report participant flow, the number analyzed per arm, endpoint completeness, exclusions, or missing-data handling. It also does not describe adherence, protocol deviations, the randomization method, allocation concealment, or who was blinded. These details are not reported in the registry record, and their absence prevents a fuller appraisal of implementation and analysis.
The record lists three outcome measures but provides limited information about secondary outcome timing and analysis, and it does not report a multiplicity strategy. The listed safety counts have no event terms and no inferential comparisons; death counts are not reported in the registry record. Finally, the study’s own sample-size justification and detailed statistical plan are not reported, so the planning assumptions cannot be treated as the protocol’s rationale.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis — NCT01993823.
- Registry record last updated 2017-04-04; status last verified 2017-03.
- Results first posted 2017-02-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed Phase III, multicenter, randomized, double-blind, parallel-group active-treatment study of G238 versus clotrimazole 1% otic solution for otomycosis. Enrollment is listed as 190. Both arms are described as five drops into the ear canal twice daily for 14 days. The primary endpoint is complete response on Day 24, based on fungal culture status and a signs-and-symptoms score; its population is labeled ITT.
The record lists changes in signs and symptoms as a secondary outcome and three outcome measures overall. It reports 0 analyses and does not provide primary efficacy results or a treatment comparison. Safety entries list 0 serious and 0 other adverse events in the G238 group among 89 at risk and in the clotrimazole group among 85 at risk. Death counts are not reported in the registry record. The statistical plan, missing-data procedures, and study-specific sample-size justification are also not reported in the registry record.