Vomiting in Infants and/or ChildrenPhase 4NCT04318847
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
A Phase 4 study testing Ondansetron 4 MG in people with Vomiting in Infants and/or Children, run by Lizar Aguirre Pascasio.
Trial summary
This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration. The target population will be children between 4 and 13 years old who present vomiting. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Vomiting in Infants and/or Children
- What is being tested?
- Ondansetron 4 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2021to 10 Apr 2023
- Phase
- Phase 4
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of at least 2 vomits in the last 4 hours.
- Negative tolerance test.
- Signature of the informed consent by the parents or legal guardians.
- Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
- Patients weighing 15 kg or more.
Who cannot join
- Altered conciousness.
- Sospected acute abdomen (appendicitis, invaginations...).
- Suspicion or presence of obstructive disease.
- Known severe digestive disease (Chron´s disease, ulcerative colitis...).
- Suspected food poisoning.
- Allergy to any of the drugs used in the study.
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- Severe dehydration.
- Bilious vomiting.
- Previous abdominal surgery.
- Pathology that may affective degree of hydration of the patient (kidney failure, hypoalbuminemia..).
- Admission requirement or intravenous rehydration for any reason.
- Concomitant use of apomorphine.
- In relation to the possible lengthening of the QT, patients with problems of previous arrhythmia should be excluded or that they are receiving concomitant medication that can lengthen the QT, that have electrolyte disturbances.
- Patients receiving other serotonergic drugs.
- Patients who have undergone a previous adenotonsillectomy.
- Patients with hypocalcemia and/or hypomagnesemia.
- Patients with hereditary fructose intolerance.
- Diabetes patients.
- Lactose intolerant patients.
- Patients with indication of the low sodium diets.
- Hypersensitivity to ondansetron or other antagonists of the 5-HT3.
Trial locations and contacts
No sites are listed yet.
About this study
This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.
The target population will be children between 4 and 13 years old who present vomiting.
- Conditions
- Vomiting in Infants and/or Children
- Being tested
- Ondansetron 4 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MGDrug
Administration of ondansetron 4 mg or 8 mg according to weight
| Study group | Role | What they receive |
|---|---|---|
| Ondransetron | Experimental | Administration of ondansetron Receives: Drug: Ondansetron 4 MG |
| Habitual Clinical Practice | No intervention | Habitual Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children who return to medical/pediatric consultation for de same episode
Is calculated percentage of children who return to medical/pediatric consultation for de same episode of vomiting
Measured: An average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start10 Oct 2021 (estimated)
- Primary completion10 Apr 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vomiting in Infants and/or ChildrenStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lizar Aguirre Pascasio
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lizar Aguirre Pascasio, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318847
- Sponsor's protocol ID
- OND-URG
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04318847
- Acronym / sponsor ID
- OND-URG
- Conditions
- Vomiting in Infants and/or Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Lizar Aguirre PascasioOther government
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 10 Apr 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 24 Mar 2020 (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.
This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.
The target population will be children between 4 and 13 years old who present vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondransetron | Experimental | Drug: Ondansetron 4 MGAdministration of ondansetron |
| Habitual Clinical Practice | No intervention | –Habitual Clinical Practice |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presence of at least 2 vomits in the last 4 hours.
- Negative tolerance test.
- Signature of the informed consent by the parents or legal guardians.
- Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
- Patients weighing 15 kg or more.
Key exclusion criteria (21 listed)
- Altered conciousness.
- Sospected acute abdomen (appendicitis, invaginations...).
- Suspicion or presence of obstructive disease.
- Known severe digestive disease (Chron´s disease, ulcerative colitis...).
- Suspected food poisoning.
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 4 MGAdministration of ondansetron 4 mg or 8 mg according to weight | Drug | Ondransetron |
Primary outcome
Percentage of children who return to medical/pediatric consultation for de same episode
Time frame: An average of 24 months
Is calculated percentage of children who return to medical/pediatric consultation for de same episode of vomiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 4 MG in people with Vomiting in Infants and/or Children, run by Lizar Aguirre Pascasio.
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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lizar Aguirre Pascasio, Dr (945007374, LIZAR.AGUIRREPASCASIO@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children who return to medical/pediatric consultation for de same episode (time frame: An average of 24 months). 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 21 Apr 2021.