NCT00337727

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 848 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	aprepitant	aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
DRUG	Comparator: ondansetron	Ondansetron 8 mg capsule Three day treatment period.
DRUG	Comparator: dexamethasone	dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
DRUG	Comparator: fosaprepitant dimeglumine	fosaprepitant dimeglumine 115 mg
DRUG	Comparator; Placebo (unspecified)	dexamethasone 12mg Pbo tablets.
DRUG	Comparator; Placebo (unspecified)	Aprepitant 80 mg \& 125 mg Pbo capsules.

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-10-28
• Completion: 2008-11-19
• First posted: 2006-06-16
• Last updated: 2017-06-02
• Results posted: 2009-11-06