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Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)

Trial Profile

Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Feb 2019

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At a glance

  • Drugs Ondansetron (Primary)
  • Indications Gastritis; Gastroenteritis; Vomiting
  • Focus Registrational; Therapeutic Use
  • Acronyms GUARD
  • Sponsors RedHill Biopharma
  • Most Recent Events

    • 09 Apr 2018 According to a RedHill Biopharma media release, following the positive results of this study and guidance provided by the FDA, the company is currently in discussions with the FDA on the design of a confirmatory phase III study (CTP 289309) to support a potential New Drug Application (NDA).
    • 27 Mar 2018 According to a RedHill Biopharma media release, data from this trial will be presented at the Society for Academic Emergency Medicine (SAEM) 2018 Annual Meeting
    • 05 Oct 2017 Status changed from active, no longer recruiting to completed.
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