Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876585
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-03-22
Brief Title:
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
Sponsor:
Genuine Research Center Egypt
Organization:
Genuine Research Center Egypt
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None