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Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00104403
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date December 2004
Completion date January 2006
View Details
See also
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