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ID

34977

Description

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the standard meal form. It has to be filled in for TP1-4 Day1.

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Versions (2)
  1. 2/4/19 2/4/19 -
  2. 2/6/19 2/6/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 6, 2019

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License

Creative Commons BY-NC 3.0
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    Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

    English

    Standard meal

    1 forms  
    1. StudyEvent: ODM
      1. Standard meal
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Standard meal
    Description

    Standard meal

    Alias
    UMLS CUI-1
    C0444664
    Start Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0444664
    Planned relative time
    Description

    Time Relative To Dosing

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0444664
    Start time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0444664
    Has the totality of the meal been ingested?
    Description

    Ingestion of meal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0205197
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    Similar models

    Standard meal

    1 forms
    1. StudyEvent: ODM
      1. Standard meal
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    TP1D1 (1)
    CL Item
    TP2D1 (2)
    CL Item
    TP3D1 (3)
    CL Item
    TP4D1 (4)
    Item Group
    Standard meal
    C0444664 (UMLS CUI-1)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0444664 (UMLS CUI [1,2])
    Item
    Planned relative time
    integer
    C0439564 (UMLS CUI [1,1])
    C0444664 (UMLS CUI [1,2])
    Planned relative time
    Code List
    Planned relative time
    CL Item
    2-3h (1)
    CL Item
    4-6h (2)
    CL Item
    8-9h (3)
    CL Item
    11-12h (4)
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1,1])
    C0444664 (UMLS CUI [1,2])
    Item
    Has the totality of the meal been ingested?
    text
    C1998602 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Ingestion of meal
    Code List
    Has the totality of the meal been ingested?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Back to the top of the page 

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