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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 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. The trial reports 2 study locations across 2 states.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02801370
The ClinicalTrials.gov registry entry for NCT02801370 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otonomy, which has 20 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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