Open-Label Study of OTO-201 for Treatment of AOMT

Completed · Phase 2

Conditions studied: Acute Otitis Media, AOMT

In brief

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.

Key facts

Study ID

NCT02408796

Run by

Otonomy, Inc.

People needed

39

Starts

2015-03-01

Expected to finish

2015-05-01

Last updated by the study team

2020-10-19

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.