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A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)

NCT01732458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2018-09-25

Study results available
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Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric participants.

Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using population PK modeling and simulation will be described in a separate report.

Conditions

  • Post-operative Nausea
  • Post-operative Vomiting

Interventions

DRUG

Aprepitant

Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.

DRUG

Placebo to Aprepitant

DRUG

Ondansetron

Administered IV at a dose of 4 mg for participants \>40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants \<1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.

DRUG

Placebo to match ondansetron

Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

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
2013-02-12
Primary Completion
2016-09-26
Completion
2016-09-26
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 NCT01732458 on ClinicalTrials.gov