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: 05 May 2023
Price :
$35
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At a glance
- Drugs Ondansetron (Primary)
- Indications Gastritis; Gastroenteritis; Vomiting
- Focus Registrational; Therapeutic Use
- Acronyms GUARD
- Sponsors RedHill Biopharma
- 28 Apr 2023 According to a RedHill Biopharma media release, discussions with potential commercialization partners ongoing.
- 16 Feb 2023 According to a RedHill Biopharma media release, following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support in adults and children over the age of 12, Data to support the submission was generated from several clinical studies including this trial.
- 26 Feb 2020 Results assessing effect of ondansetron on the corrected QTc (n=147) published in the American Journal of Emergency Medicine.