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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

NCT01165866

Gastroenteritis

COMPLETED PHASE4

Symptomatic Treatment of Acute Gastroenteritis

NCT01257672

Gastroenteritis Vomiting Acute Gastroenteritis

COMPLETED PHASE3

Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

NCT00972595

Chemotherapy-Induced Nausea and Vomiting

COMPLETED PHASE1

Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition

NCT01578265

Fed

COMPLETED PHASE1

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

NCT00108095

Postoperative Nausea and Vomiting Nausea and Vomiting, Postoperative

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroenteritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ondansetron 8 mg ampoule

Intervention Type DRUG

Study drug

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

Group Type ACTIVE_COMPARATOR

Metoclopramide 10 mg ampoule

Intervention Type DRUG

Comparator drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ondansetron 8 mg ampoule

Study drug

Intervention Type DRUG

Metoclopramide 10 mg ampoule

Comparator drug

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Danset ampoule Primperan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No