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A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer

Trial Profile

A Multicenter, Randomized, Phase 2 Study to Assess the Feasibility, Safety and Efficacy of OTO-104 Given by Intratympanic Administration in Subjects at Risk for Ototoxicity From Cisplatin Chemotherapy Regimens in the Treatment of Cancer

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 26 May 2025

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Hearing loss
  • Focus Therapeutic Use
  • Sponsors Otonomy [CEASED]

Most Recent Events

  • 21 May 2025 Results assessing feasibility, safety, and trends of the efficacy of intratympanic injections of sustained-exposure dexamethasone thermosensitive gel (OTO-104) for otoprotection, published in the Pediatric Blood and Cancer.
  • 14 Sep 2017 Planned End Date changed from 1 Jun 2018 to 1 Sep 2017.
  • 13 Sep 2017 Status changed from recruiting to discontinued according to an Otonomy media release.

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