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NCT02801370 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of OTO-201 in Acute Otitis Externa
A Phase 3 study of Acute Otitis Externa and Swimmer's Ear, sponsored by Otonomy.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
- 2
- Study locations
NCT02801370: Completed Phase 3 study of Acute Otitis Externa and Swimmer's Ear, sponsored by Otonomy.
NCT02801370 is a Phase 3 study of Acute Otitis Externa and Swimmer's Ear that has completed, run by Otonomy. The registered enrollment target is 262 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02801370, a Phase 3 study of Acute Otitis Externa and Swimmer's Ear, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG 12 mg ciprofloxacin
- DRUG Sham Control
Study Locations (2)
California
- Call Otonomy call center for trial locations - San Diego
Other
- Call Otonomy call center for trial locations - Saskatoon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2016-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT02801370 record still lists
NCT02801370 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Acute Otitis Externa appearing as the primary indexed condition, and to 2 interventions - of which 12 mg ciprofloxacin is the first listed.
NCT02801370 reports a single indexed study location in California, Other.
Frequently Asked Questions
What is clinical trial NCT02801370 about?
NCT02801370 is a clinical study titled "Phase 3 Study of OTO-201 in Acute Otitis Externa". This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the ...
What is the current status of trial NCT02801370?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2016-06. Estimated completion is 2016-12.
What conditions does trial NCT02801370 study?
This clinical trial studies the following conditions: Acute Otitis Externa, Swimmer's Ear.
What interventions are being tested in trial NCT02801370?
The interventions under investigation include: 12 mg ciprofloxacin (DRUG), Sham Control (DRUG).
Who is sponsoring clinical trial NCT02801370?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02801370 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Otitis Externa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02801370's enrollment target sits among peer trials
262 1228th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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