NCT06208917

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

Efficacy of Ondansetron Oral Soluble Film Combined With Dexamethasone Versus Ondansetron Intravenously Combined With Dexamethasone in Prophylaxis of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients : A Multi-center, Randomized, Parallel Controlled, Non-inferior Clinical Study.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Yizhuo Zhang · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Complete randomization was used to assign subjects to the experimental group (ondansetron oral soluble film plus dexamethasone) and the control group (ondansetron intravenously plus dexamethasone) in a ratio of 1 to 1. And a specialized software was used to generate random numbers to make a random assignment table. Experimental: Participants received the first dose of ondansetron oral soluble film (age-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose for whom younger than 12 years old while the others should be given 8h hours after the first dose. Ondansetron oral soluble film was administered continuously for two days after chemotherapy according to the administration regimen on the day of chemotherapy. Dexamethasone (weight based) iv/po twice daily and discontinued until 72 hours after chemotherapy. Placebo Comparator: Participants received the first dose of ondansetron intravenously (weight-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose. Ondansetron (po) was given for next continuously two days in the same dose and frequency of administration. Dexamethasone (weight based) iv/po twice daily and discontinued until 72 hours after chemotherapy.

Conditions

• Pediatric Solid Tumor, Unspecified, Protocol Specific

Interventions

Type	Name	Description
DRUG	Ondansetron (Oral soluble film OR injections) ,Dexamethasone	Participants will randomly assigned 1:1 to receive treatment (Oral soluble film of Ondansetron plus dexamethasone OR Ondansetron injections plus dexamethasone).

Timeline

• Start date: 2023-07-09
• Primary completion: 2026-07-01
• Completion: 2027-01-31
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: China