drugset / Trial / NCT00819039

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

NCT00819039

Phase 1 Completed 98 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified Oral
Comparator Ondansetron Other / unclassified Intravenous

Indications

No indication recorded.