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Phase 3 Study of OTO-201 in Acute Otitis Externa

NCT02801370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2020-10-19

Study results available
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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

  • Acute Otitis Externa
  • Swimmer's Ear

Interventions

DRUG

12 mg ciprofloxacin

Single administration of OTO-201

DRUG

Sham Control

Simulated, single adminstration

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Otonomy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801370 on ClinicalTrials.gov