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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

Trial Profile

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

Status: Completed
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
  • Most Recent Events

    • 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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