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

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement Clinical Trial

Official title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Intratympanic Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Status Completed

Clinical Trial Summary

The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
• Otitis Media with Effusion

• NCT number: NCT01949142
• Study type: Interventional
• Source: Otonomy, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Completion date: May 2014