A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Trial Profile

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2017

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms AVERTS-1
  • Sponsors Otonomy
  • Most Recent Events

    • 30 Aug 2017 Results published in an Otonomy media release.
    • 30 Aug 2017 Primary endpoint has not been met. (Reduction in number of definitive vertigo days compared to placebo), according to an Otonomy media release.
    • 16 Aug 2017 Status changed from active, no longer recruiting to completed.
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