Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGenuine Research Center, Egypt

About this trial

A Randomized, Open-label, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Ondansetron compared to Metoclopramide in the management of Nausea and Vomiting in Adult Patients with Acute Gastroenteritis.

Eligibility criteria

Qualifiers

Male or female patients aged between 18 and 65 years.

Patients diagnosed with acute gastroenteritis visiting the emergency room.

Patients considered by the attending physician to need an anti-emetic medication.

Patients able and willing to provide written informed consent.

Disqualifiers

Pregnant or lactating women.

Patients who received an anti-emetic medication during the past 24 hours.

History of hypersensitivity to any components of ondansetron or metoclopramide injection.

History of hypersensitivity to other selective 5HT3 receptor antagonists.

Trial design

Treatments tested in this trial

  • Ondansetron 8 mg ampoule
  • Metoclopramide 10 mg ampoule

Treatment groups

126 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Genuine Research Center, Egypt

Lead sponsor

Adwia Pharma, Egypt

Collaborator