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.
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.
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.
Parallel
Ondansetron 8 mg ampoule
DrugStudy drug
Metoclopramide 10 mg ampoule
DrugComparator drug
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
The number of adverse events and serious adverse events
Comparison between the number of adverse events and serious adverse events reported in the ondansetron 8 mg group and the metoclopramide 10 mg group
Overall patient's satisfaction with the tolerability of the study medication
Measured by asking the patient
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Genuine Research Center, Egypt
Lead sponsor
Adwia Pharma, Egypt
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
