A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1

Merck Sharp & Dohme LLC0 sites477 target enrollmentJanuary 13, 2004

ConditionsNausea Vomiting

DrugsMK0869, aprepitant / Duration of Treatment: 3 days Comparator: ondansetron / Duration of Treatment: 4 days

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Nausea
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 477
Primary Endpoint: Patient vomiting
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.

Registry

clinicaltrials.gov

Start Date

January 13, 2004

End Date

September 30, 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel