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

Genuine Research Center

Status and phase: Begins enrollment this month; Phase 3

Conditions: Gastroenteritis

Treatments: Drug: Ondansetron 8 mg ampoule; Drug: Metoclopramide 10 mg ampoule

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05876585

GRC/ADGE/EG/38/III

Details and patient eligibility

About

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.

Full 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: 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients aged between 18 and 65 years.
2. Patients diagnosed with acute gastroenteritis visiting the emergency room.
3. Patients considered by the attending physician to need an anti-emetic medication.
4. Patients able and willing to provide written informed consent.
5. Patients able and willing to complete the study procedures including compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

1. Pregnant or lactating women.
2. Patients who received an anti-emetic medication during the past 24 hours.
3. History of hypersensitivity to any components of ondansetron or metoclopramide injection.
4. History of hypersensitivity to other selective 5HT3 receptor antagonists.
5. Patients with moderate or severe impairment of hepatic function.
6. Patients with moderate or severe renal impairment.
7. Patients with congenital long QT syndrome.
8. 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.
9. Patients with hypokalemia or hypomagnesemia.
10. Patients with signs of subacute intestinal obstruction.
11. Patients currently using apomorphine hydrochloride.
12. Patients currently using levodopa or dopamine agonists.
13. Patients with gastrointestinal hemorrhage, mechanical obstruction, or gastrointestinal perforation.
14. Patients with a known history of neuroleptic- or metoclopramide-induced tardive dyskinesia.
15. Patients with epilepsy.
16. Patients with Parkinson's disease.
17. Patients with confirmed or suspected pheochromocytoma.
18. Patients with a known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase deficiency.
19. 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.
20. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
21. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
22. Inability to understand and cooperate with the investigators or to give valid consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Ondansetron 8 mg ampoule

Experimental group

Description:

A clear, colorless, sterile solution for injection or infusion. Each 1 ml of the solution contains 2 mg of ondansetron as hydrochloride dihydrate.

Treatment:

Drug: Ondansetron 8 mg ampoule

Metoclopramide 10 mg ampoule

Active Comparator group

Description:

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

Treatment:

Drug: Metoclopramide 10 mg ampoule