Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

NCT00366834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1840

Last updated 2012-09-10

No results posted yet for this study

Summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Conditions

Interventions

DRUG

Casopitant (GW679769) oral tablets

DRUG

Casopitant (GW679769) intravenous

DRUG

Dexamethasone intravenous

DRUG

Ondansetron oral tablets

DRUG

placebo

casopitant placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-10-31
Completion
2009-10-31

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Pakistan
  • Peru
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00366834 on ClinicalTrials.gov