Diarrhea Clinical Trial
Official title:
Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
Verified date | April 2018 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | April 2005 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 10 Years |
Eligibility |
Inclusion Criteria: - Acute gastroenteritis - Non-bilious and non-bloody vomiting within 4 hours of triage - Diarrhea - Mild to moderate dehydration Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Ann & Robert H Lurie Children's Hospital of Chicago, GlaxoSmithKline, National Center for Research Resources (NCRR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization. |
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