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OTO-201 for the Treatment of Otitis Externa

NCT02511561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-10-19

Study results available
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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.

Conditions

  • Otitis Externa

Interventions

DRUG

OTO-201 (ciprofloxacin)

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Otonomy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

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 NCT02511561 on ClinicalTrials.gov