Dose Ranging Study of OTO-201 in AOMT

NCT02719158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-10-19

Study results available
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Summary

Dose Ranging Study of OTO-201 in AOMT

Conditions

  • Acute Otitis Media
  • AOMT

Interventions

DRUG

6 mg ciprofloxacin

Single administration of OTO-201

DRUG

12 mg ciprofloxacin

Single administration of OTO-201

OTHER

Sham

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Otonomy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-07-31

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 NCT02719158 on ClinicalTrials.gov