NCT05876585

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

A Randomized, Double-Blinded, Placebo-Controlled, Phase III 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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: 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.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
DRUG	Ondansetron 8 mg ampoule	Study drug
DRUG	Metoclopramide 10 mg ampoule	Comparator drug

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-05-25
• Last updated: 2024-09-26