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.

Sponsor

Genuine Research Center, Egypt (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05876585

Collaborator

Adwia Pharma, Egypt (Other)

126

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroenteritis	Drug: Ondansetron 8 mg ampoule Drug: Metoclopramide 10 mg ampoule	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron 8 mg ampoule 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 Study drug Other Names: Danset ampoule
Active Comparator: Metoclopramide 10 mg ampoule 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 Comparator drug Other Names: Primperan

Arm

Intervention/Treatment

Experimental: Ondansetron 8 mg ampoule

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

Study drug

Other Names:

Danset ampoule

Active Comparator: Metoclopramide 10 mg ampoule

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

Comparator drug

Other Names:

Primperan

Outcome Measures

Primary Outcome Measures

The proportion of patients experiencing complete control of nausea and vomiting [6 hours after receiving the study medication]
Measured by asking the patient hourly to assess their nausea and vomiting.
The proportion of patients experiencing complete control of nausea and vomiting [24 hours after receiving the study medication]
Measured by asking the patient hourly to assess their nausea and vomiting.
The proportions of patients who experienced nausea, vomiting, or retching. [6 hours hours after receiving the study medication]
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
The proportions of patients who experienced nausea, vomiting, or retching. [24 hours after receiving the study medication]
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
The proportion of patients who needed intravenous rehydration [24 hours after receiving the study medication]
Assessed as per physician's discretion
The proportion of patients who needed a rescue anti-emetic medication [24 hours after receiving the study medication]
Assessed as per physician's discretion
The duration of stay at the emergency room before discharge [From date of admission until the date of discharge, up to 3 hours]
The duration from admission to discharge from the emergency room
Overall patient's and physician's satisfaction with the efficacy of the study medication [24 hours after receiving the study medication]
Measured by asking the patient and the physician

Secondary Outcome Measures

The number of adverse events and serious adverse events [24 hours after receiving the study medication]
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 [24 hours after receiving the study medication]
Measured by asking the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Genuine Research Center, Egypt
Adwia Pharma, Egypt

Investigators

Principal Investigator: Waleed El-Nabawy, MD, Ph.D, Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
Principal Investigator: Tarek Ibrahim, MD, Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt