A Confirmatory Phase III Study of BEKINDA 24 mg for Acute Gastroenteritis or Gastritis

Trial Profile

A Confirmatory Phase III Study of BEKINDA 24 mg for Acute Gastroenteritis or Gastritis

Planning
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2018

At a glance

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

    • 09 Apr 2018 According to a RedHill Biopharma media release, the company is currently in discussions with the FDA on the design of this confirmatory phase III study to support a potential New Drug Application (NDA).
    • 11 Oct 2017 New trial record
    • 03 Oct 2017 According to a RedHill Biopharma media release, data from this trial will support a New Drug Application (NDA) with BEKINDA 24 mg for acute gastroenteritis and gastritis.
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