Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371014
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-15
Brief Title:
Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy
Sponsor:
Shanghai Childrens Medical Center
Organization:
Shanghai Childrens Medical Center
Study Overview
Official Title:
Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
Ondansetron
Brief Summary:
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A Ondansetron mouth soluble film or arm-B Ondansetron tablet Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone Children recruited to arm-B received Ondansetron tablet plus dexamethasone Ondansetron and dexamethasone were given continuously until 48hours 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?:
None
Is an FDA AA801 Violation?:
None