drugset / Trial / NCT00337727

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

NCT00337727

Phase 3 Completed 848 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindPrevention

Summary

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Timeline

Start
2007-01-01
Primary completion
2008-10-28
Completion
2008-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 80 mg Oral
Subject fosaprepitant dimeglumine Unknown 115 mg Intravenous
Background Dexamethasone Small molecule 12 mg Oral
Background Dexamethasone Small molecule 20 mg Oral
Background Ondansetron Other / unclassified 8 mg Oral