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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

NCT05876585 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ondansetron 8 mg ampoule

Study drug

DRUG

Metoclopramide 10 mg ampoule

Comparator drug

Sponsors & Collaborators

  • Adwia Pharma, Egypt

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Waleed El-Nabawy, MD, Ph.D · Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt

  • Tarek Ibrahim, MD · Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt

  • Ahmed Dabour, MD, Ph.D · Department of Internal Medicine, Faculty of Medicine, Benha University, Benha, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-06-01
Completion
2025-06-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876585 on ClinicalTrials.gov