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A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

NCT00819039 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-01-26

Study results available
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Summary

This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Aprepitant

Aprepitant administered orally or intraveously.

DRUG

Ondansetron

Ondansetron administered intravenously.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-26
Primary Completion
2013-03-12
Completion
2013-03-12

Countries

  • United States
  • Brazil
  • Mexico
  • Spain
  • Turkey (Türkiye)

Study Locations

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Entities

Companies

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 NCT00819039 on ClinicalTrials.gov