Trial · NCT02801370
Phase 3 Study of OTO-201 in Acute Otitis Externa
NCT02801370, Phase 3, Completed, Otonomy, Inc.; results first posted 2020-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of OTO-201 in Acute Otitis Externa. Trials, record NCT02801370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02801370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of OTO-201 in Acute Otitis Externa
- NCT number
- NCT02801370
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 262 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Acute Otitis Externa, Swimmer's Ear
- Interventions
- 12 mg ciprofloxacin, Sham Control
- First posted
- 2016-06-15
- Last updated
- 2020-10-19
- Results first posted
- 2020-09-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Considered a Clinical Cure at Day 8 | At Day 8 (1 week after dosing) | 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 |
| Secondary | Number of Subjects Considered a Clinical Cure at Day 15 | At Day 15 (2 weeks after dosing) | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Considered a Clinical Cure at Day 8 | At Day 8 (1 week after dosing) | Intent-to-treat analysis set: All subjects who were randomized and did not have Group A Streptococci cultured on Day 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Considered a Clinical Cure at Day 15 | At Day 15 (2 weeks after dosing) | Intent-to-treat analysis set: All subjects who were randomized and and did not have Group A Streptococci cultured on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 8 | 12 mg OTO-201 | 91 | Participants | ||
| Number of Subjects Considered a Clinical Cure at Day 8 | Control | 63 | Participants | ||
| Number of Subjects Considered a Clinical Cure at Day 15 | 12 mg OTO-201 | 97 | Participants | ||
| Number of Subjects Considered a Clinical Cure at Day 15 | Control | 69 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 12 mg OTO-201 | 130 | |
| Overall Study | STARTED | Control | 132 | |
| Overall Study | COMPLETED | 12 mg OTO-201 | 123 | |
| Overall Study | COMPLETED | Control | 132 | |
| Overall Study | NOT COMPLETED | 12 mg OTO-201 | 7 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Otitis externa | Infections and infestations | 12 mg OTO-201 | 3 | 127 | |
| other | Otitis externa | Infections and infestations | Control | 9 | 132 | |
| other | Ear Pain | Ear and labyrinth disorders | 12 mg OTO-201 | 3 | 127 | |
| other | Ear Pain | Ear and labyrinth disorders | Control | 3 | 132 | |
| other | Ear pruritis | Ear and labyrinth disorders | 12 mg OTO-201 | 3 | 127 | |
| other | Ear pruritis | Ear and labyrinth disorders | Control | 2 | 132 | |
| other | Erythema | Skin and subcutaneous tissue disorders | 12 mg OTO-201 | 0 | 127 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Control | 3 | 132 | |
| other | Headache | Nervous system disorders | 12 mg OTO-201 | 3 | 127 | |
| other | Headache | Nervous system disorders | Control | 1 | 132 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 12 mg OTO-201 | 0 | 127 |
| Total, all-cause mortality | Control | 0 | 132 |
| Total, other adverse events | 12 mg OTO-201 | 12 | 127 |
| Total, other adverse events | Control | 18 | 132 |
| Total, serious adverse events | 12 mg OTO-201 | 0 | 127 |
| Total, serious adverse events | Control | 0 | 132 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 12 mg OTO-201 vs Control: Number of Subjects Considered a Clinical Cure at Day 15 | Trial comparisons |
| 12 mg OTO-201 vs Control: Number of Subjects Considered a Clinical Cure at Day 8 | Trial comparisons |
| 12 mg OTO-201 vs Control: deaths from any cause | Trial comparisons |
| 12 mg OTO-201 vs Control: serious adverse events | 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/NCT02801370
GET https://conductscience.org/api/trials/v1/NCT02801370/registered