drugset / Trial / NCT01755286

OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

NCT01755286 ↗

Phase 1 Completed 83 enrolled Otonomy, Inc.
RandomizedSingle-groupTriple-blindTreatment

Summary

The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Timeline

Start
2012-12
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject OTO-201 Unknown 4 mg Other
Subject OTO-201 Unknown 12 mg Other