Post-operative Nausea Clinical Trial
Official title:
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting
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.
Because the opportunity to collect specimens for PK analyses in children will be limited, a flexible sparse sampling scheme using ranges of collection times will be utilized which will limit the burden to participants. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01725399 -
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?
|
N/A | |
| Completed |
NCT01592708 -
Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
|
N/A |