Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pediatric Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 617 years
- Gender
- Both males and females
Description
Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner. Experimental:...
Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner. Experimental: Participants received a single dose of fosaprepitant (age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy. Placebo Comparator: Participants received a single dose of matched placebo for fosaprepitant administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.
Tracking Information
- NCT #
- NCT04508400
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yizhuo Zhang Sun Yat-sen University
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