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A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

NCT00818259 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-09-25

Study results available
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Summary

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Experimental: aprepitant

aprepitant powder for suspension, 125 mg/sachet, PO

DRUG

Experimental: fosaprepitant

fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV

DRUG

Comparator: ondansetron

ondansetron solution for infusion, IV, administered per local standard of care

DRUG

Ondansetron

ondansetron solution for infusion, IV, administered per local standard of care

DRUG

Dexamethasone

dexamethasone solution for infusion, IV, administered per local standard of care

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-05
Primary Completion
2014-01-20
Completion
2014-01-20

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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 NCT00818259 on ClinicalTrials.gov