NCT00952341

Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Conditions

• Chemotherapy-induced Nausea and Vomiting (CINV)

Interventions

Type	Name	Description
DRUG	aprepitant	Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
DRUG	Comparator: Placebo to aprepitant	Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
DRUG	dexamethasone	Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
DRUG	granisetron	Day 1: IV granisetron 3 mg prior to administration of cisplatin
DRUG	dexamethasone	Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Timeline

• Start date: 2009-08-25
• Primary completion: 2010-04-04
• Completion: 2010-05-05
• First posted: 2009-08-06
• Last updated: 2017-06-02
• Results posted: 2011-09-27