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.
This is a phase III, randomized, open-label, active-controlled, two-arm, parallel-design, interventional clinical trial evaluating the efficacy and safety of ondansetron 8 mg IV/ IM injection compared to metoclopramide 10 mg in the management of nausea and vomiting in adult patients with acute gastroenteritis. Study duration: 1 year for patients' enrollment and follow-up. Sample Size: 63 subjects per arm, 126 in total. Participants in the trial will be male and female patients aged between 18 and 65 years visiting the emergency room due to acute gastroenteritis. Patients will be screened for eligibility and eligible patients will be randomized in a 1:1 allocation ratio to receive a single dose of ondansetron 8 mg injection (arm 1) or a single dose of metoclopramide 10 mg injection (arm 2). Randomization will be done using interactive web response technology. After drug administration, the patients will be followed up for 24 hours, including at least 3 hours in the emergency room immediately after drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Study drug
Comparator drug
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
Time frame: 6 hours after receiving the study medication
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
Time frame: 24 hours after receiving the study medication
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
Time frame: 6 hours hours after receiving the study medication
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
Time frame: 24 hours after receiving the study medication
The proportion of patients who needed intravenous rehydration
Assessed as per physician's discretion
Time frame: 24 hours after receiving the study medication
The proportion of patients who needed a rescue anti-emetic medication
Assessed as per physician's discretion
Time frame: 24 hours after receiving the study medication
The duration of stay at the emergency room before discharge
The duration from admission to discharge from the emergency room
Time frame: From date of admission until the date of discharge, up to 3 hours
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Overall patient's and physician's satisfaction with the efficacy of the study medication
Measured by asking the patient and the physician
Time frame: 24 hours after receiving the study medication
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
Time frame: 24 hours after receiving the study medication
Overall patient's satisfaction with the tolerability of the study medication
Measured by asking the patient
Time frame: 24 hours after receiving the study medication