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A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension

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Trial Profile

A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Adverse reactions
  • Acronyms EARN 3459
  • Sponsors Otonomy [CEASED]

Most Recent Events

  • 13 Jun 2016 Status changed from active, no longer recruiting to completed.
  • 28 Mar 2016 Planned primary completion date changed from 1 Oct 2015 to 1 Apr 2016 as per ClinicalTrials.gov record.
  • 20 Apr 2015 Planned End Date changed from 1 Mar 2016 to 1 Apr 2016 as per ClinicalTrials.

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