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Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

NCT02600559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2020-10-19

Study results available
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Summary

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Conditions

  • Otitis Media

Interventions

DRUG

OTO-201 (ciprofloxacin)

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Principal Investigators

  • Dean Hakanson, MD · Otonomy, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-07-31
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 NCT02600559 on ClinicalTrials.gov