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A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting

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Trial Profile

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2009

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At a glance

  • Drugs Palonosetron (Primary)
  • Indications Postoperative nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Helsinn Healthcare SA

    • Most Recent Events

    • 05 Mar 2008 New trial record.
    • 02 Mar 2008 Primary endpoint 'Complete clinical response rate' has been met.
    • 02 Mar 2008 The US FDA has approved palonosetron for use in postoperative nausea and vomiting based on results from this study.

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