Nausea and Vomiting in Pediatric Age GroupNCT06175806
Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group
A study testing Ondansetron Oral Film and Granisetron Oral Liquid Product in people with Nausea and Vomiting in Pediatric Age Group, run by Ain Shams University at 1 site in Egypt.
Trial summary
The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Nausea and Vomiting in Pediatric Age Group
- What is being tested?
- Ondansetron Oral Film and Granisetron Oral Liquid Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.
Who cannot join
- Patients who are severely dehydrated.
- Patients who have bloody vomiting.
- Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.
- Patients who have vomiting due to surgical causes like intestinal obstruction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial
The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).
- Being tested
- Ondansetron Oral Film, Granisetron Oral Liquid Product
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron Oral FilmDrug
5-hydroxytryptamine (5-HT) receptor antagonist
Granisetron Oral Liquid ProductDrug
5-hydroxytryptamine (5-HT) receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| arm I (group A) who will receive dispersible film ondansetron | Experimental | arm I (group A) who will receive dispersible film ondansetron in a dose of 4 mg for those who will weigh more than 15 Kg up to 30 kg, and 8 mg for those who will weigh more than 30 Kg. The dose will be repeated if the patient had another vomiting episode within 15 minutes of taking the medicine. Receives: Drug: Ondansetron Oral Film |
| Arm II (group B) who will receive oral Granisetron | Experimental | Arm II (group B) who will receive oral Granisetron in a dose of 40 microgram/kg/dose; the dose could be repeated if needed after 12 hours. Receives: Drug: Granisetron Oral Liquid Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.
The number of vomiting episodes.
Measured: at 6 hours and at 48 hours of adminsteration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start10 Sep 2023
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting in Pediatric Age GroupStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Essam Ibrahim, Ain Shams University
- Investigators
- Mohamed F Allam, MD, Principal investigator, Professor of Family Medicine, Faculty of Medicine, Ain shams UniversityMay F Nassar, MD, Study director, Professor of pediatrics, Faculty of Medicine, Ain shams UniversityEhab K Emam, MD, Study chair, Professor of pediatrics, Faculty of Medicine, Ain shams UniversityHaya E Ibrahim, MD, Principal investigator, lecturer of pediatrics,Faculty of Medicine, Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175806
- Sponsor's protocol ID
- FMASU MS 519/2023
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06175806
- Acronym / sponsor ID
- FMASU MS 519/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm I (group A) who will receive dispersible film ondansetron | Experimental | Drug: Ondansetron Oral Filmarm I (group A) who will receive dispersible film ondansetron in a dose of 4 mg for those who will weigh more than 15 Kg up to 30 kg, and 8 mg for those who will weigh more than 30 Kg. The dose will be repeated if the patient had another vomiting episode within 15 minutes of taking the medicine. |
| Arm II (group B) who will receive oral Granisetron | Experimental | Drug: Granisetron Oral Liquid ProductArm II (group B) who will receive oral Granisetron in a dose of 40 microgram/kg/dose; the dose could be repeated if needed after 12 hours. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.
Key exclusion criteria (4 listed)
- Patients who are severely dehydrated.
- Patients who have bloody vomiting.
- Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.
- Patients who have vomiting due to surgical causes like intestinal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron Oral Film5-hydroxytryptamine (5-HT) receptor antagonist | Drug | arm I (group A) who will receive dispersible film ondansetron |
| Granisetron Oral Liquid Product5-hydroxytryptamine (5-HT) receptor antagonist | Drug | Arm II (group B) who will receive oral Granisetron |
Primary outcome
To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.
Time frame: at 6 hours and at 48 hours of adminsteration
The number of vomiting episodes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed F Allam, MD principal investigator
Professor of Family Medicine, Faculty of Medicine, Ain shams University
May F Nassar, MD study director
Professor of pediatrics, Faculty of Medicine, Ain shams University
Ehab K Emam, MD study chair
Professor of pediatrics, Faculty of Medicine, Ain shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron Oral Film and Granisetron Oral Liquid Product in people with Nausea and Vomiting in Pediatric Age Group, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients. (time frame: at 6 hours and at 48 hours of adminsteration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.