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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2017

At a glance

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

    • 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.
    • 17 Jul 2017 Primary endpoint (Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose) has been met according to a RedHill Biopharma media release.
    • 14 Jun 2017 According to a RedHill Biopharma media release, the company will host a conference call and webcast call to review top-line results.
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