drugset / Trial / NCT00104403

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

NCT00104403

Phase 2 Completed 722 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Casopitant Small molecule 50 mg Oral
Subject Casopitant Small molecule 100 mg Oral
Subject Casopitant Small molecule 150 mg Oral
Background Dexamethasone Small molecule
Background Ondansetron Other / unclassified