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Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Nausea and Vomiting, Chemotherapy-Induced

Chemotherapy-Induced Nausea and Vomiting

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

Detailed 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 Combinatio...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
  • Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
  • Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
  • Exclusion criteria:
  • Not received any investigational product within 30 days of enrollment into the study.
  • Must not be pregnant.
  • Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
  • Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
  • Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
  • Must not have a history of peptic ulcer disease.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2006

    Estimated Enrollment :

    722 Patients enrolled

    Trial Details

    Trial ID

    NCT00104403

    Start Date

    December 1 2004

    End Date

    January 1 2006

    Last Update

    April 16 2015

    Active Locations (113)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 29 (113 locations)

    1

    GSK Investigational Site

    Birmingham, Alabama, United States, 35209

    2

    GSK Investigational Site

    Corona, California, United States, 92882

    3

    GSK Investigational Site

    Greenbrae, California, United States, 94904-2007

    4

    GSK Investigational Site

    Loma Linda, California, United States, 92354