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

NCT00337727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 848

Last updated 2017-06-02

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2008-10-28
Completion
2008-11-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337727 on ClinicalTrials.gov