A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antago...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000370-31

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects

Femme Homme

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Extrait

The primary objective of this clinical trial is to determine the optimal single dose of oral GW679769 when administered in combination with intravenous (IV) ondansetron hydrochloride for the prevention of emesis (defined as vomiting or retching) during the first 24 hours following the emergence from anesthesia in female subjects with known risk factors for post-operative nausea and vomiting (PONV) who are undergoing surgical procedures that are associated with an increased emetogenic risk.


Critère d'inclusion

  • Post Operative Nausea and Vomiting (PONV) Post Discharge Nausea and Vomiting (PDNV)