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A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.

NCT00601172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2018-01-17

Study results available
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Summary

This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.

Conditions

  • Nausea and Vomiting, Chemotherapy-Induced

Interventions

DRUG

Casopitant

Experimental NK-1 receptor antagonist

DRUG

Dexamethasone

Standard antiemetics

DRUG

Placebo

Placebo to match IV casopitant

DRUG

Ondansetron

Standard antiemetics

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-10
Primary Completion
2009-04-13
Completion
2009-04-13

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Russia
  • Slovakia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
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 NCT00601172 on ClinicalTrials.gov