Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women

Overview

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

Full Title of Study: “A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2006

Interventions

  • Drug: GW679769 (casopitant)

Arms, Groups and Cohorts

  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

  • Rates of vomiting and retching
    • Time Frame: after surgery

Secondary Measures

  • Rates of nausea. Blood test results.
    • Time Frame: after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • History of PONV and/or motion sickness. – Have not smoked for the last 6 months. – Having certain types of abdominal, breast or shoulder surgeries. Exclusion criteria:

  • Pregnant or breastfeeding. – Taking certain medications. – Have certain pre-existing medical conditions.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.

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