Comparison · NCT02717442-355d395e
OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3). Trial comparisons, record NCT02717442-355d395e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02717442-355d395e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.0838 | wilson | |
| Risk in group 2 | 0.0784 | 0.0309 | 0.185 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0784 | -0.185 | 0.0179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on OTO-104 (Safety Analysis Set) than on Placebo (Safety Analysis Set) | 12.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | OTO-104 (Safety Analysis Set) | All subjects who receivedOTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 0 | 42 | OG000 |
| Group 2 | Placebo (Safety Analysis Set) | All subjects who received Placebo. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 4 | 51 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
- Description
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 2000 Hz. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
- Time frame
- 3 months
- Population
- Subjects that had no impairment at the baseline visit (air-bone gap \<=10 dB) and had an audiogram collected at the Week 12 (Month 3) visit.
Source ClinicalTrials.gov
Trial
- Title
- Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- NCT number
- NCT02717442
- Phases
- PHASE3
- Conditions
- Meniere's Disease
- Interventions
- OTO-104, Placebo
- Lead sponsor
- Otonomy, Inc.
- Results first posted
- 2023-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02717442?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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