A Phase 3 interventional study of Ondansetron 8 mg ampoule and Metoclopramide 10 mg ampoule in Gastroenteritis, sponsored by Genuine Research Center, Egypt. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Genuine Research Center, Egypt · Phase 3, Interventional, and Treatment
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.
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's planned enrollment of 126 is close to the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Genuine Research Center, Egypt is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Study drug
Also known as: Danset ampoule
Comparator drug
Also known as: Primperan
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
Time frame: 6 hours after receiving the study medication
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
Time frame: 24 hours after receiving the study medication
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
Time frame: 6 hours hours after receiving the study medication
The proportions of patients who experienced nausea, vomiting, or retching.
Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
Time frame: 24 hours after receiving the study medication
The proportion of patients who needed intravenous rehydration
Assessed as per physician's discretion
Time frame: 24 hours after receiving the study medication
The proportion of patients who needed a rescue anti-emetic medication
Assessed as per physician's discretion
Time frame: 24 hours after receiving the study medication
The duration of stay at the emergency room before discharge
The duration from admission to discharge from the emergency room
Time frame: From date of admission until the date of discharge, up to 3 hours
Overall patient's and physician's satisfaction with the efficacy of the study medication
Measured by asking the patient and the physician
Time frame: 24 hours after receiving the study medication
The number of adverse events and serious adverse events
Comparison between the number of adverse events and serious adverse events reported in the ondansetron 8 mg group and the metoclopramide 10 mg group
Time frame: 24 hours after receiving the study medication
Overall patient's satisfaction with the tolerability of the study medication
Measured by asking the patient
Time frame: 24 hours after receiving the study medication
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2025; primary completion for Jun 2025, 0 months later.
Of 21 industry-sponsored phase 3 interventional studies under Gastroenteritis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 0 months is below that.
Counting every sponsor, half of 25 studies reached it within 19 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ondansetron
Genuine Research Center, Egypt →