Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Phase of Trial: Phase III
Latest Information Update: 01 Jul 2018
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At a glance
- Drugs Ciprofloxacin (Primary)
- Indications Otitis media
- Focus Registrational; Therapeutic Use
- Sponsors Otonomy
- 18 Mar 2016 Results of this trial were published in JAMA Otolaryngology-Head & Neck Surgery, according to an Otonomy media release.
- 18 Mar 2016 Results published in an Otonomy media release.
- 10 Nov 2015 According to an Otonomy Inc. media release, results of this study were presented at the 2015 American Academy of Otolaryngology - Head & Neck Surgery Foundation (AAO-HNSF) Annual Meeting.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History