GastroenteritisNCT00120744
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
A study testing Ondansetron Oral Disintegrating Tablet in people with Gastroenteritis and Vomiting, run by The Hospital for Sick Children.
Trial summary
The objectives of the study were to determine whether ondansetron treatment would reduce: the amount of vomiting in the emergency department; the need for intravenous rehydration; and the need for hospitalization. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Gastroenteritis, Vomiting, Diarrhea
- What is being tested?
- Ondansetron Oral Disintegrating Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2004to Apr 2005
- 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute gastroenteritis
- Non-bilious and non-bloody vomiting within 4 hours of triage
- Diarrhea
- Mild to moderate dehydration
Who cannot join
- Weight less than 8 kilograms
- Severe dehydration
- Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)
- History of abdominal surgery
- Hypersensitivity to the drug or any components in its formulation
About this study
Official title: Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
The objectives of the study were to determine whether ondansetron treatment would reduce:
- the amount of vomiting in the emergency department;
- the need for intravenous rehydration; and
- the need for hospitalization.
Read the detailed description
Background:
Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase.
Methods:
The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.
- Conditions
- Gastroenteritis, Vomiting, Diarrhea, Dehydration
- Being tested
- Ondansetron Oral Disintegrating Tablet
- Medical subject headings
- Gastroenteritis, Vomiting, Diarrhea, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron Oral Disintegrating TabletDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.
Secondary outcomes (1)
To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startJan 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), GlaxoSmithKline, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Stephen Freedman, The Hospital for Sick Children
- Investigators
- Stephen B Freedman, MDCM, MSCI, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120744
- Sponsor's protocol ID
- 2003-12038
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2005
- Last updated
- 17 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00120744
- Acronym / sponsor ID
- 2003-12038
- Conditions
- Gastroenteritis, Vomiting, Diarrhea, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), GlaxoSmithKline, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Jan 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 19 Jul 2005 (estimated)
- 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 objectives of the study were to determine whether ondansetron treatment would reduce:
- the amount of vomiting in the emergency department;
- the need for intravenous rehydration; and
- the need for hospitalization.
Detailed description
Background:
Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase.
Methods:
The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Acute gastroenteritis
- Non-bilious and non-bloody vomiting within 4 hours of triage
- Diarrhea
- Mild to moderate dehydration
Key exclusion criteria (5 listed)
- Weight less than 8 kilograms
- Severe dehydration
- Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)
- History of abdominal surgery
- Hypersensitivity to the drug or any components in its formulation
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 Disintegrating Tablet | Drug | – |
Primary outcome
The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.
1 secondary outcome
To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.
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 17 Apr 2018.
- PublicationLink provided by the sponsor.
Related trials for Gastroenteritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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.
Stephen B Freedman, MDCM, MSCI principal investigator
The Hospital for Sick Children
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron Oral Disintegrating Tablet in people with Gastroenteritis and Vomiting, run by The Hospital for Sick Children.
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 4 inclusion and 5 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 17 Apr 2018. 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.
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?
The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.. 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 17 Apr 2018.