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A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Pr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005855-16

A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Femme Homme

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Extrait

The primary objective of this study is to demonstrate the superiority of 30 mg intravenous GW679769, in combination with a single 4 mg intravenous dose of ZOFRAN (ondansetron hydrochloride), over a single 4 mg intravenous dose of ZOFRAN (ondansetron hydrochloride) alone in the control of emesis during the first 24 hours following placement of the last suture/staple (as measured by complete response, defined as no vomiting, no retching, no rescue medications) in surgical subjects who are predicted to have a high risk of emesis.

Critère d'inclusion

  • Postoperative Nausea and Vomiting (PONV)

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