A Confirmatory Phase III Study of BEKINDA 24 mg for Acute Gastroenteritis or Gastritis
Phase of Trial: Phase III
Latest Information Update: 12 Sep 2018
At a glance
- Drugs Ondansetron (Primary)
- Indications Gastritis; Gastroenteritis
- Focus Registrational; Therapeutic Use
- Sponsors RedHill Biopharma
- 12 Sep 2018 According to a RedHill Biopharma media release, the company concluded a positive End-of-Phase II/Pre-Phase III (Type B) meeting with the U.S. FDA to discuss planned endpoints and design of the trial.
- 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