A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)

Femme et Homme

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Extrait

1. To demonstrate that aprepitant 40 mg is superior to ondansetron 4 mg IV with respect to the proportion of patients with No Vomiting in the 24 hours following end of surgery. 2. To demonstrate that aprepitant 40 mg is non-inferior to ondansetron with respect to the proportion of patients with Complete Response in the 24 hours following end of surgery. If non-inferiority is established the following will also be evaluated: Aprepitant 40 mg is superior to ondansetron with respect to the proportion of patients with Complete Response in the 24 hours following end of surgery. 3. To evaluate the safety and tolerability of aprepitant 40 mg in patients undergoing surgery.

Critère d'inclusion

postoperative nausea and vomiting

Liens

euctr
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A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Pre...