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A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

NCT00431236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2017-08-22

No results posted yet for this study

Summary

This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.

Conditions

  • Nausea and Vomiting, Chemotherapy-Induced

Interventions

DRUG

Oral Casopitant (GW679769)

DRUG

IV Casopitant (GW679769)

DRUG

IV ondansetron hydrochloride

DRUG

Oral dexamethasone

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-06
Primary Completion
2007-10-09
Completion
2007-10-09

Countries

  • Argentina
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Finland
  • Greece
  • Hungary
  • India
  • Ireland
  • Italy
  • Malaysia
  • Pakistan
  • Philippines
  • Poland
  • Romania
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT00431236 on ClinicalTrials.gov