Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children

Recruiting Phase 3 Interventional Study
Pediatric Solid Tumor, Unspecified, Protocol Specific
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
376 (estimated)
Sponsor
Yizhuo Zhang · Other
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About This Trial

The purpose is to evaluate the efficacy of ondansetron oral soluble film plus dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HEC chemotherapy in children with solid tumor.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Children aged 6 months to 18 years at the time of randomization; 2. Diagnosed of solid tumor by cytological or histological examination; 3. Going to initiate MEC/HEC chemotherapy; 4. PS score ≤ 2 points; 5. predicted life expectancy ≥3 months and weight greater than 6Kg; 6. P…
Contacts

Yizhuo Zhang

+86 87342460

zhangyzh@sysucc.org.cn

CONTACT

Yizhuo Zhang

+8687342460

zhangyzh@sysucc.org.cn

CONTACT