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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2017

At a glance

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

    • 05 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 10 Aug 2017 According to a RedHill Biopharma media release, outcome of a Type B FDA meeting regarding this trial is expected to be announced in October 2017.
    • 25 Jul 2017 According to a RedHill Biopharma media release, the company expects a Type B FDA meeting regarding Phase III GUARD study of BEKINDA 24 mg, by October 2017.
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