NCT00120744

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

July 12, 2005

Last Update Submit

April 16, 2018

Conditions

GastroenteritisVomitingDiarrheaDehydration

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Ondansetron Oral Disintegrating TabletDRUG

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acute gastroenteritis
  • Non-bilious and non-bloody vomiting within 4 hours of triage
  • Diarrhea
  • Mild to moderate dehydration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

GastroenteritisVomitingDiarrheaDehydration

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • Stephen B Freedman, MDCM, MSCI

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Scientist

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Start

January 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 17, 2018

Record last verified: 2018-04