Clinical trial · Interventional
Heart Safety Study of Ondansetron in Children Receiving Chemotherapy
The Effects of Ondansetron on Myocardial Repolarization in Children Receiving Chemotherapy
NCT01896440CI-TRIAL-00012333withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FDA did not approve
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Childhood Neoplasm | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ondansetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A - standard ondansetron dose first
- description
- Group A will receive the standard dose of ondansetron (0.15 mg/kg) with the first cycle of chemotherapy and the high dose (0.3 mg/kg) with second cycle.
- interventionNames
- Drug: Ondansetron
- type
- ACTIVE_COMPARATOR
- label
- Group B - high dose ondansetron first
- description
- Group B patients will receive the higher dose of ondansetron (0.3 mg/kg) with the first cycle of chemotherapy and the standard dose (0.15 mg/kg) with the second.
- interventionNames
- Drug: Ondansetron
Primary outcomes (1)
- measure
- Change in QTc interval
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.