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

Phase 2 Completed 229 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2013-02-12
Primary completion: 2016-09-26
Completion: 2016-09-26

Publications

Salman FT, DiCristina C, Chain A, Afzal AS. Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects. J Pediatr Surg. 2019 Jul;54(7):1384-1390. doi: 10.1016/j.jpedsurg.2018.09.006. Epub 2018 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprepitant	Other / unclassified	10 mg	Oral
Subject	Aprepitant	Other / unclassified	40 mg	Oral
Subject	Aprepitant	Other / unclassified	125 mg	Oral
Comparator	Ondansetron	Other / unclassified	0.1 mg/kg	Intravenous
Comparator	Ondansetron	Other / unclassified	4 mg	Intravenous

Indications

No indication recorded.