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



Status:Completed
Conditions:Other Indications, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 17
Updated:7/28/2016
Start Date:October 2015
End Date:July 2016

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Trial Summary
Trial Overview
Inclusion Criteria

An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

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.


Inclusion Criteria includes, but is not limited to:

- Subject is a male or female aged 6 months to 17 years, inclusive

- Subject has a history of otitis media requiring bilateral tympanostomy tube placement

- Subject's caregiver is willing to comply with the protocol and attend all study
visits

Exclusion Criteria includes, but is not limited to:

- Subject has a history of prior ear or mastoid surgery, not including myringotomy or
myringotomy with TT placement

- Subject has been designated for any other surgical procedure that would occur
concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal
endoscopy, and nasal cautery for epistaxis

- Subject has a history of sensorineural hearing loss
We found this trial at
1
site
Email Otonomy Central Contact for Trial Locations
San Diego, California 92121
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San Diego, CA
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