Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Completed · Phase 3
Conditions studied: Otitis Media
In brief
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.
Key facts
- Study ID
- NCT02600559
- Run by
- Otonomy, Inc.
- People needed
- 501
- Starts
- 2015-10-01
- Expected to finish
- 2016-07-01
- 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
- Email Otonomy Central Contact for Trial Locations — San Diego, California, United States
Full record on ClinicalTrials.gov
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