Status:
WITHDRAWN
Heart Safety Study of Ondansetron in Children Receiving Chemotherapy
Lead Sponsor:
University of Oklahoma
Conditions:
Malignant Childhood Neoplasm
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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.
Detailed Description
Children receiving chemotherapy for cancer at the Jimmy Everest Center for Cancer and Blood Disorders in Children also often receive an IV dose of an antiemetic for prophylaxis. The most common antiem...
Eligibility Criteria
Inclusion
- Age 6 months to 18 years
- Diagnosis of cancer and receiving 2 identical cycles of chemotherapy within 2 months of each other
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01896440
Start Date
October 1 2013
End Date
October 1 2013
Last Update
October 8 2013
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104