Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01636947
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2012-07-05
Brief Title:
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy Non-doxorubicin Hydrochloride Adriamycin and Cyclophosphamide Regimens MK-0869-225 KMEC
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Korean Multicenter Randomized Double-Blind Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies MEC Non-AC Regimes With Broad Range of Tumor Types KMEC Study
Status:
COMPLETED
Status Verified Date:
2018-08
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:
KMEC
Brief Summary:
This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy MEC in participants with solid tumors MECs include a number of commonly used cancer chemotherapeutic drugs including oxaliplatin-based irinotecan-based and carboplatin-based regimens
The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control ondansetron Regimen with respect to the percentage of participants with No Vomiting Overall in the 120 hours following initiation of MEC in participants with solid tumors
The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control ondansetron Regimen with respect to the percentage of participants with No Vomiting Overall in the 120 hours following initiation of MEC in participants with solid tumors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-0869-225 | OTHER | Merck protocol number | None |