A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b 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

Trial Profile

A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b 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

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Feb 2016

At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Otitis media
  • Focus Adverse reactions; First in man
  • Sponsors Otonomy
  • Most Recent Events

    • 10 Jun 2011 Planned initiation date changed from 1 Jun 2011 to 1 Dec 2011.
    • 23 Feb 2011 New trial record
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