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Heart Safety Study of Ondansetron in Children Receiving Chemotherapy

NCT01896440 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-10-08

No results posted yet for this study

Summary

We will study the effects of ondansetron on measurements of electrical activity in the heart to make sure doses we are using to prevent nausea and vomiting in children receiving chemotherapy are safe.

Conditions

  • Malignant Childhood Neoplasm

Interventions

DRUG

Ondansetron

There will be two doses investigated in each arm - standard dose (0.15 mg/kg) and high dose (0.3 mg/kg)

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Rene Y McNall-Knapp, MD · University of Oklahoma

  • Matthew Campbell, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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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 NCT01896440 on ClinicalTrials.gov