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NOT YET RECRUITING
NCT07035821
PHASE3

Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

Sponsor: Shanghai Children's Medical Center

View on ClinicalTrials.gov

Summary

Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.

Official title: Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial

Key Details

Gender

All

Age Range

5 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-01

Completion Date

2026-07-30

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DRUG

Olanzapine Tablets

Oral olanzapine tablets

DRUG

Placebo

Oral placebo

Locations (1)

Shanghai Children's Medical Center

Shanghai, China