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A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
Central California Ear, Nose and Throat
Fresno, California, United States
South Florida Pediatric Otolaryngology
Fort Lauderdale, Florida, United States
Charlotte Eye, Ear, Nose and Throat Associates
Charlotte, North Carolina, United States
Charlotte Eye, Ear, Nose and Throat Associates
Matthews, North Carolina, United States
Carolina Ear, Nose and Throat
Orangeburg, South Carolina, United States
Start Date
March 1, 2015
Primary Completion Date
May 1, 2015
Completion Date
May 1, 2015
Last Updated
October 19, 2020
39
ACTUAL participants
OTO-201
DRUG
Lead Sponsor
Otonomy, Inc.
NCT05651633
NCT02591563
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02567825