Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080444
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2004-03-31
Brief Title:
Study of Aprepitant MK-0869 for Chemotherapy-Induced Nausea and Vomiting CINV in Adolescent Participants MK-0869-097
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Study Conducted Under In-House Blinding Conditions to Examine the Safety Tolerability and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients
Status:
COMPLETED
Status Verified Date:
2014-08
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:
None
Brief Summary:
This study is being conducted to demonstrate that aprepitant MK-0869 prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants Participants treated with emetogenic cancer chemotherapies that include either cisplatin cyclophosphamide or carboplatin or participants who experienced nausea andor vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study In the double-blind Part 1 of this study enrolled participants will be randomized to receive either aprepitant or standard therapy In Part 2 of this study enrolled participants will receive open-label aprepitant
Detailed Description:
The duration of treatment is the first 4 days of one 28-day cycle Cycle 1 Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional open-label 28-day cycles
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 |
|---|---|---|---|
| 2004_099 | OTHER | Telerx Protocol Number | None |
| Formerly-0304AHEC | None | None | None |
| MK-0869-097 | OTHER | None | None |