Last updated: 11/04/2018 09:44:34

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

GSK study ID
NKT102260
See study documents
Clinicaltrials.gov ID
NCT00108095
EudraCT ID
2004-000370-31
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 Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk
Trial description: This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: intravenous ondansetron
    • Enrollment:
    701
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II Study to Evaluate the Safety and Efficacy of the Oral Neurokinin-1 Receptor Antagonist Casopitant (GW679769) Administered with Ondansetron for the Prevention of Postoperative and Postdischarge Nausea and Vomiting in High-risk Patients. [Anesthesiology]. 2010;113(1):74-82.
    Medical condition
    Postoperative Nausea and Vomiting
    Product
    casopitant, ondansetron
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to August 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Females age 18-55
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Females age 18-55
    • Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal Exclusion criteria:
    • Pregnant or breastfeeding
    • Post-menopausal
    • Not undergoing general anesthesia

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Aachen, Nordrhein-Westfalen, Germany, 52074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marburg, Hessen, Germany, 35043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Koblenz, Rheinland-Pfalz, Germany, 56073
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cadiz, Spain, 11009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Kansas, United States, 66160
    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
    2005-08-08

    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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