MedTrace Logo

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

NCT00104403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2015-04-16

No results posted yet for this study

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.

Conditions

  • Nausea and Vomiting, Chemotherapy-Induced
  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

GW679769

DRUG

Dexamethasone

DRUG

Ondansetron Hydrochloride

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Mexico
  • Pakistan
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

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 NCT00104403 on ClinicalTrials.gov