Last updated: 11/07/2018 17:45:07

Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

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GSK study ID
NKT102552
See study documents
Clinicaltrials.gov ID
NCT00334152
See results summary
EudraCT ID
2005-005855-16
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 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
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:
Not applicable
Allocation:
Randomized
Primary outcomes:

Number of participants who achieved a complete response

Timeframe: Up to 24 hours

Secondary outcomes:

The severity of nausea experienced by participants in each cohort during the 0–24 hours, 24-48 hours and 0-48 hours periods, as assessed by an 11-point, linear, numerical rating scale referred to as a “0–10 Likert scale”

Timeframe: 0–24 hours, 24-48 hours and 0-48 hours

Number of Participants According to Severity of Nausea in Each Cohort During the 0–24 hours, 24-48 hours and 0-48 hours Periods, as Assessed by a Categorical Scale (None, Mild, Moderate or Severe), as Defined in the Protocol

Timeframe: 0–24 hours, 24-48 hours and 0-48 hours

Number of participants with first emetic event

Timeframe: Up to 48 hours

Number of participants with first antiemetic rescue medication

Timeframe: Up to 48 hours

Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary

Timeframe: Up to 48 hours

Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary

Timeframe: Up to 48 hours

Number of participants with chemistry data outside the reference range

Timeframe: Baseline (Screening), Day 1/2 and Days 6-14

Number of participants with hematology data outside the reference range

Timeframe: Baseline (Screening), Day 1/2 and Days 6-14

Time to Awakening From Anesthesia

Timeframe: Up to 24 hours

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Days 6–14

Interventions:
  • Drug: Placebo
  • Drug: ondansetron HCL
  • Drug: GW679769
    • Enrollment:
    514
    Primary completion date:
    2006-13-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chung, F; Singla, S, Grenier, A; Kutsogiannis, D; Kett, A; Pergolizzi, J; Russo, M. A Phase III Study to Evaluate Efficacy and Safety of IV Casopitant for Prevention of PONV in High-Risk Female Patients. Eur J Anaesthesiol
    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 (postoperative nausea and vomiting) and/or motion sickness.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • History of PONV (postoperative nausea and vomiting) and/or motion sickness.
    • Have not smoked for the last 6 months.
    • Having certain abdominal, breast, thyroid or shoulder surgery. Exclusion criteria:
    • Pregnant or breastfeeding.
    • Have certain pre-existing medical conditions or take certain medications.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kiel, Schleswig-Holstein, Germany, 24105
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santiago de Compostela, Spain, 15706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 4G2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moscow, Russia, 101000
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-13-07
    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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