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A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical Application Into the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

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Trial Profile

A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical Application Into the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 12 Feb 2024

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At a glance

  • Drugs ASP 0598 (Primary)
  • Indications Ear disorders; Tympanic membrane perforation
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Astellas Pharma Global Development
  • Most Recent Events

    • 11 Jul 2023 Status changed from recruiting to discontinued due to lack of Efficacy.
    • 13 Jun 2023 Study design changed from Sequential to parallel assignment.
    • 28 Sep 2022 Planned End Date changed from 28 Feb 2023 to 30 Jun 2024.

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