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Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan

NCT01870648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 918

Last updated 2018-03-02

No results posted yet for this study

Summary

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan.

SOME Dehydration is defined as 2 or more of the following signs and symptoms:

* Restlessness, irritability
* Sunken Eyes
* Drinks eagerly, thirsty
* Skin pinch goes back slowly

Conditions

Interventions

DRUG

Ondansetron

Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.

DRUG

Placebo

Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Aga Khan University

    collaborator OTHER

  • Dr. Stephen Freedman

    lead OTHER

Principal Investigators

  • Stephen Freedman, MD · University of Calgary

  • Zulfiqar Bhutta, MD · Aga Khan University - World Health Organization

  • Sajid B Soofi, MD · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Pakistan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870648 on ClinicalTrials.gov