NCT00090207

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	MK0869, aprepitant / Duration of Treatment: 3 days
DRUG	Comparator: ondansetron / Duration of Treatment: 4 days

Timeline

• Start date: 2004-01-13
• Primary completion: 2004-09-30
• Completion: 2004-09-30
• First posted: 2004-08-27
• Last updated: 2017-04-24