This Study Will Assess the Efficacy and Safety of Ondansetron Compared to Metoclopramide in the Management of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis.

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 6 months 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.

Official Title
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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

Conditions
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Gastroenteritis

Intervention / Treatment
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* Drug: Ondansetron 8 mg ampoule
* Drug: Metoclopramide 10 mg ampoule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patients able and willing to complete the study procedures including compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: 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. Patients with moderate or severe impairment of hepatic function. Patients with moderate or severe renal impairment. Patients with congenital long QT syndrome. Patients who have or may develop prolongation of Qtc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmia, or patients taking other medicinal products that lead to QT prolongation or electrolyte imbalance. Patients with hypokalemia or hypomagnesemia. Patients with signs of subacute intestinal obstruction. Patients currently using apomorphine hydrochloride. Patients currently using levodopa or dopamine agonists. Patients with gastrointestinal hemorrhage, mechanical obstruction, or gastrointestinal perforation. Patients with a known history of neuroleptic- or metoclopramide-induced tardive dyskinesia. Patients with epilepsy. Patients with Parkinson's disease. Patients with confirmed or suspected pheochromocytoma. Patients with a known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase deficiency. Patients with a history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial. Inability to understand and cooperate with the investigators or to give valid consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron 8 mg ampoule<br>A clear, colorless, sterile solution for injection or infusion. Each 1 ml of the solution contains 2 mg of ondansetron as hydrochloride dihydrate. | Drug: Ondansetron 8 mg ampoule<br>* Study drug<br>* Other names: Danset ampoule;|
| Active Comparator: Metoclopramide 10 mg ampoule<br>Metoclopramide 10 mg/ 2 ml solution for injection in ampoules. Each 2 ml of the solution contains 10 mg of metoclopramide hydrochloride equivalent to 10 mg of anhydrous metoclopramide | Drug: Metoclopramide 10 mg ampoule<br>* Comparator drug<br>* Other names: Primperan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients experiencing complete control of nausea and vomiting | Measured by asking the patient hourly to assess their nausea and vomiting. | 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. | 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. | 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. | 24 hours after receiving the study medication | 
| The proportion of patients who needed intravenous rehydration | Assessed as per physician's discretion | 24 hours after receiving the study medication | 
| The proportion of patients who needed a rescue anti-emetic medication | Assessed as per physician's discretion | 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 | From date of admission until the date of discharge, up to 3 hours | 
| Overall patient's and physician's satisfaction with the efficacy of the study medication | Measured by asking the patient and the physician | 24 hours after receiving the study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours after receiving the study medication | 
| Overall patient's satisfaction with the tolerability of the study medication | Measured by asking the patient | 24 hours after receiving the study medication |