Last updated: 11/04/2018 09:44:59

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

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GSK study ID
NKT102553
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Clinicaltrials.gov ID
NCT00326248
EudraCT ID
2005-005856-42
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Rates of vomiting and retching

Timeframe: after surgery

Secondary outcomes:

Rates of nausea. Blood test results.

Timeframe: after surgery

Interventions:
  • Drug: GW679769 (casopitant)
    • Enrollment:
    482
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Altorjay A, Melson T, Chinachoti T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV. Casopitant and Ondansetron for Postoperative Nausea and Vomiting Prevention in Women at High Risk for Emesis: A Phase 3 Study. [Arch Surg]. 2011;146(2):201-206.
    Medical condition
    Nausea and Vomiting, Postoperative
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to July 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • History of PONV and/or motion sickness.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Jackson, Mississippi, United States, 39202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lyon, France, 69008
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sheffield, Alabama, United States, 35660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Livingston, West Lothian, United Kingdom, EH54 6PP
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Brunswick, New Jersey, United States, 8903
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Naples, Florida, United States, 34108
    Status
    Study Complete
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    Showing 1 - 6 of 57 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-13-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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