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Continuous Infusion vs Push Injection of Ondansetron and Dexamethasone for CINV in Pediatric Cancer
NCT05872893Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2023
- Primary completion
- Jan 2025
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- chemotherapy-induced nausea and vomiting (CINV)
01
Overview
Phase 3 trial of ondansetron and dexamethasone in chemotherapy-induced nausea and vomiting (CINV) (2 arms), sponsored by Immune Oncology Research Institute. Primary endpoint: Mean nausea score per patient at 20 months. Started Jun 2023; status: completed.
02
Design
2 armsondansetron + dexamethasone, continuous infusion
Continuous infusion of age-adjusted doses of ondansetron 5mg/m2 in combination with dexamethasone 4mg/m2
ondansetron + dexamethasone, push injection
Standard i/v push injections of ondansetron 5mg/m2 and dexamethasone 4mg/m2
03
Who it enrols
Pediatric cancer patients eligible for chemotherapy with sufficient cardiac function, excluding those with hypersensitivity to 5-HT3 antagonists, concurrent chemo-radiation, cardiac arrhythmias, or long QT syndrome.
04
Endpoints
Primary
Mean nausea score per patient
Secondary
Correlation between mean nausea score and demographic variables
Correlation between mean nausea score and disease characteristics
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