Comparison · NCT02801370-a9ded781
12 mg OTO-201 vs Control: Number of Subjects Considered a Clinical Cure at Day 15
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. 12 mg OTO-201 vs Control: Number of Subjects Considered a Clinical Cure at Day 15. Trial comparisons, record NCT02801370-a9ded781. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02801370-a9ded781
On this page
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 | 0.746 | 0.665 | 0.813 | wilson | |
| Risk in group 2 | 0.531 | 0.445 | 0.614 | wilson | |
| Risk difference, group 1 minus group 2 | 0.215 | 0.0988 | 0.324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 1.16 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 2.6 | 1.54 | 4.39 | log | |
| Number needed to treat, for one more participant with the outcome on 12 mg OTO-201 than on Control | 4.64 | 3.09 | 10.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration | 97 | 130 | OG000 |
| Group 2 | Control | Sham control: Simulated, single administration | 69 | 130 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects Considered a Clinical Cure at Day 15
- Description
- Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:~None = 0 Mild = 1 Moderate = 2 Severe = 3
- Time frame
- At Day 15 (2 weeks after dosing)
- Population
- Intent-to-treat analysis set: All subjects who were randomized and and did not have Group A Streptococci cultured on Day 1.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of OTO-201 in Acute Otitis Externa
- NCT number
- NCT02801370
- Phases
- PHASE3
- Conditions
- Acute Otitis Externa, Swimmer's Ear
- Interventions
- 12 mg ciprofloxacin, Sham Control
- Lead sponsor
- Otonomy, Inc.
- Results first posted
- 2020-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02801370?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02801370-a9ded781