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ID

33999

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Dummy Dose form. It has to be filled in for TP1-4 for each D-1.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Keywords

  1. 1/9/19 1/9/19 -
  2. 1/10/19 1/10/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

    Dummy Dose

    1. StudyEvent: ODM
      1. Dummy Dose
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Treatment period and Day
    Description

    Treatment type/Treatment period and Day

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Dummy Dose
    Description

    Dummy Dose

    Alias
    UMLS CUI-1
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI-2
    C0304229 (Experimental drug)
    Date of Dummy dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032042 (Placebos)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of Dummy dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0032042 (Placebos)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2

    Similar models

    Dummy Dose

    1. StudyEvent: ODM
      1. Dummy Dose
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Treatment period and Day
    integer
    C0087111 (UMLS CUI [1])
    Code List
    Treatment period and Day
    CL Item
    TP1D-1  (1)
    (Comment:en)
    CL Item
    TP2D-1 (2)
    (Comment:en)
    CL Item
    TP3D-1 (3)
    (Comment:en)
    CL Item
    TP4D-1 (4)
    (Comment:en)
    Item Group
    Dummy Dose
    C3174092 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    Date of Dummy dose
    Item
    Date of Dummy dose
    date
    C0032042 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time of Dummy dose
    Item
    Time of Dummy dose
    time
    C0032042 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])

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