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Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)

NCT01697579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-06-25

Study results available
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Summary

The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to \<17 years of age. Fosaprepitant is a prodrug to aprepitant. All participants who completed the randomized Cycle 1 could elect to receive open-label fosaprepitant during optional Cycles 2-6.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Fosaprepitant

Administered intravenously (IV) as a single dose

DRUG

Fosaprepitant Placebo

Administered IV as a single dose

DRUG

Ondansetron

Administered IV according to local labeling and/or local standard of care

DRUG

5-hydroxytryptamine 3 antagonist

Administered IV according to local labeling and/or local standard of care

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-13
Primary Completion
2016-11-21
Completion
2016-11-21
FDA Drug
Yes

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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 NCT01697579 on ClinicalTrials.gov