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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.

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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).

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

FieldValue
Enrollment Target 262 participants
Start Date 2016-06
Est. Completion 2016-12
Phase Phase 3

Sponsor

Otonomy

20 total trials

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.

Similar trials for Acute Otitis Externa

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.