Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873284
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-04-22
Brief Title:
Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients
Sponsor:
Shanghai Childrens Medical Center
Organization:
Shanghai Childrens Medical Center
Study Overview
Official Title:
Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Cancer PatientsA Superiority Design Phase III Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None