Heart Safety Study of Ondansetron in Children Receiving Chemotherapy

• Status: Withdrawn
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Age 6 months to 18 years

• Diagnosis of cancer and receiving 2 identical cycles of chemotherapy within 2 months of each other

Exclusion Criteria:

• History of cardiac conduction anomalies, myocardial infarction, structural heart abnormalities (even if repaired)

• Pregnant or of child-bearing age and unwilling to take a pregnancy test

• Potassium or calcium outside of reference range at screening

• Liver enzymes (AST/ALT) or bilirubin >/= 2 x the upper limit of normal at screening