NCT07217600

Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy

Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.

Conditions

• Radiotherapy-induced Nausea and Vomiting (RINV)
• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Ondansetron orodispersible film once	Take ondansetron orodispersible film once 1-2 hours before each radiotherapy
DRUG	Ondansetron orodispersible film twice	Take ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-10-16
• Last updated: 2025-10-20

Locations

1 site across 1 country: China