drugset
drugset / Trial / NCT00394966

A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)

NCT00394966 ↗

Phase 2 Completed 450 enrolled Schering-Plough
RandomizedParallel-groupDouble-blindPrevention

Summary

This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.

Timeline

Start
2006-09
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rolapitant Small molecule 10 mg Oral
Subject Rolapitant Small molecule 25 mg Oral
Subject Rolapitant Small molecule 100 mg Oral
Subject Rolapitant Small molecule 200 mg Oral

Indications

No indication recorded.