Genuine Research Center, Egypt
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.
Gastroenteritis
Ondansetron 8 mg ampoule
Metoclopramide 10 mg ampoule
Phase 3
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 Type : | Interventional |
Estimated Enrollment : | 126 participants |
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 |
Actual Study Start Date : | June 2023 |
Estimated Primary Completion Date : | October 2023 |
Estimated Study Completion Date : | October 2023 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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