Last updated: 11/07/2018 17:52:36

Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

GSK study ID
NKV20001
See study documents
Clinicaltrials.gov ID
NCT00169572
EudraCT ID
2004-000371-34
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: See Detailed Description
Trial description: This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Aprepitant
  • Drug: Ondansetron
  • Drug: GW679769
  • Drug: Dexamethasone
    • Enrollment:
    492
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Roila F, Rolski J, Ramlau R, Dediu M, Russo MW, Bandekar RR, Grunberg SM. Randomized, double-blind, dose-ranging trial of the oral neurokinin-1 receptor antagonist casopitant mesylate for the prevention of cisplatin-induced nausea and vomiting. Ann Oncol. 2009;20(11): 1867-73.
    Medical condition
    Nausea and Vomiting, Chemotherapy-Induced
    Product
    casopitant, ondansetron
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to December 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
    • Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
    • Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria:
    • Not received any investigational product within 30 days of enrolment into the study.
    • Must not be pregnant.
    • Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
    • Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
    • Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
    • Must not have a history of peptic ulcer disease.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Karachi, Pakistan, 54000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lahore, Pakistan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Taipei, Taiwan, 114
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Vienna, Austria, A-1090
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Vienna, Austria, A-1130
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Salzburg, Austria, A-5020
    Status
    Study Complete
    Contact us
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    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
    2005-09-12

    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

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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