drugset / Trial / NCT02600559

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

NCT02600559

Phase 3 Completed 501 enrolled Otonomy, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-10
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciprofloxacin Small molecule 6 mg

Indications