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NCT02511561 · ClinicalTrials.gov registry record · Phase 2
OTO-201 for the Treatment of Otitis Externa
A Phase 2 study of Otitis Externa, sponsored by Otonomy.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT02511561: Completed Phase 2 study of Otitis Externa, sponsored by Otonomy.
NCT02511561 is a Phase 2 study of Otitis Externa that has completed, run by Otonomy. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511561, a Phase 2 study of Otitis Externa, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
Primary Outcome
Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)
Conditions Studied
Interventions
- DRUG OTO-201 (ciprofloxacin)
Study Locations (1)
California
- Email Otonomy Central Contact for Trial Locations - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2015-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT02511561 record still lists
NCT02511561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Otitis Externa appearing as the primary indexed condition, and to 1 intervention - of which OTO-201 (ciprofloxacin) is the first listed.
NCT02511561 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02511561 about?
NCT02511561 is a clinical study titled "OTO-201 for the Treatment of Otitis Externa". This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with...
What is the current status of trial NCT02511561?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2015-07. Estimated completion is 2015-11.
What conditions does trial NCT02511561 study?
This clinical trial studies the following conditions: Otitis Externa.
What interventions are being tested in trial NCT02511561?
The interventions under investigation include: OTO-201 (ciprofloxacin) (DRUG).
Who is sponsoring clinical trial NCT02511561?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02511561 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02511561's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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