At a glance
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A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
In Brief
A Phase 1 clinical trial evaluating Aprepitant and Ondansetron for Postoperative Nausea and Vomiting. Completed, enrolled 98 participants across 6 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Aprepitant administered orally or intraveously.
Ondansetron administered intravenously.