Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104403
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2005-02-28
Brief Title:
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-blind Placebo-controlled Dose-ranging Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients Subjects will be asked to complete daily diaries while on study medication In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study
Detailed Description:
A Phase II Multicenter Randomized Double-blind Placebo-controlled Dose-ranging Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
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