Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394966
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2006-10-31
Brief Title:
A Multicenter Randomized Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting Study P04351AM2COMPLETED
Sponsor:
Schering-Plough
Organization:
Schering-Plough
Study Overview
Official Title:
A Phase 2 MultiCenter Randomized Placebo-Controlled Double-Blind Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting CINV in Subjects Receiving Highly Emetogenic Chemotherapy HEC
Status:
COMPLETED
Status Verified Date:
2009-10
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 is a Phase 2 randomized multicenter parallel-group double-blind placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1 Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6 The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire FLIE will be used to measure the effect of chemotherapy-induced nausea and vomiting CINV on daily life Blood samples for SCH 619734 pharmacokinetic assessments will be collected The study is to be conducted in conformance with Good Clinical Practice
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 |
|---|---|---|---|
| Study ID 3283299 | None | None | None |