NCT04873284 — drugset

Summary

Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant). Children recruited to arm-A received intravenous granisetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with aprepitant. Granisetron and dexamethasone were given continuously until 48 hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy.

Timeline

Start: 2021-05-01
Primary completion: 2021-12-25
Completion: 2021-12-30

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprepitant	Other / unclassified	2 mg/kg	Oral
Subject	Fosaprepitant	Other / unclassified	4 mg/kg	Intravenous
Background	Dexamethasone	Small molecule	2 mg	Intravenous
Background	Dexamethasone	Small molecule	4 mg	Intravenous
Background	Granisetron	Other / unclassified	40 ug/kg	Intravenous

Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients

Summary

Timeline

Publications

Drugs

Indications