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You can access this
clinical trial
if you have
Post-operative Nausea or Post-operative Vomiting
and you are
under 17
years old
Phase
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Aprepitant
  • Drug: Placebo to Aprepitant
  • Drug: Ondansetron
  • Drug: Placebo to match ondansetron
Tris trial is registered with FDA with number: NCT01732458. The sponsor of the trial is Merck Sharp & Dohme Corp. and it is looking for 229 volunteers for the current phase.
Official trial 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