drugset / Trial / NCT00080444

Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

NCT00080444

Phase 3 Completed 50 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindPrevention

Summary

This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.

Timeline

Start
2004-04
Primary completion
2006-09
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 80 mg Oral
Subject Dexamethasone Small molecule 4 mg Oral
Subject Dexamethasone Small molecule 8 mg Oral
Background Ondansetron Other / unclassified 0.15 mg/kg Intravenous

Indications

No indication recorded.