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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2023

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy [CEASED]

    • Most Recent Events

    • 01 Jul 2023 Results assessing the efficacy of intratympanic OTO-104 for the treatment of Meniere's disease from NCT02717442, NCT02612337, NCT03664674 studies, published in the Otology and Neurotology.
    • 22 Feb 2021 Primary endpoint (The number of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population using the Negative Binomial Model) has not been met, according to an Otonomy media release.
    • 22 Feb 2021 Topline results presented in an Otonomy media release.

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