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41258

Descrição

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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Versões (1)
  1. 28/07/2020 28/07/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

28 de julho de 2020

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Licença

Creative Commons BY 4.0
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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    Inglês

    PGx-Pharmacogenetic Research; Concomitant Medications

    1 Formulários  
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrição

    Subject Identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    PGx-Pharmacogenetic Research
    Descrição

    PGx-Pharmacogenetic Research

    Alias
    UMLS CUI-1
    C2347500
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Descrição

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    Date informed consnet obtained for PGx-Pharmacogenetic research
    Descrição

    Date informed consnet obtained for PGx-Pharmacogenetic research

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    If no informed consent has been obtained, check one reason
    Descrição

    If no informed consent has been obtained, check one reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C1882120
    UMLS CUI [1,4]
    C0566251
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    Descrição

    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    Date sample taken
    Descrição

    Date sample taken

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1302413
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Descrição

    Has subject withdrawn consent for PGx-Pharmacogenetic research?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Has a request been made for sample destruction?
    Descrição

    Has a request been made for sample destruction?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    If a request has been made for sample destruction, check one reason
    Descrição

    If a request has been made for sample destruction, check one reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    If other reason for request for sample destruction, specify
    Descrição

    If other reason for request for sample destruction, specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C2348235
    Concomitant Medications
    Descrição

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Descrição

    Were any concomitant medications taken by the subject during the study?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Concomitant Medications
    Descrição

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Descrição

    Trade Name preferred

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013227
    Unit Dose
    Descrição

    Unit Dose

    Tipo de dados

    float

    Alias
    UMLS CUI [1]
    C0869039
    Units
    Descrição

    Units

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Descrição

    Frequency

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Descrição

    Route

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medication
    Descrição

    Reason for Medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Medication Start Date
    Descrição

    Medication Start Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication Start Time
    Descrição

    Medication Start Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2826734
    UMLS CUI [1,2]
    C1301880
    Medication taken prior to study?
    Descrição

    Medication taken prior to study?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Medication Stop Date
    Descrição

    Medication Stop Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Medication Stop Time
    Descrição

    Medication Stop Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1]
    C2826659
    Ongoing Medication?
    Descrição

    Ongoing Medication?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    Similar models

    PGx-Pharmacogenetic Research; Concomitant Medications

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    PGx-Pharmacogenetic Research
    C2347500 (UMLS CUI-1)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Date informed consnet obtained for PGx-Pharmacogenetic research
    Item
    Date informed consnet obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If no informed consent has been obtained, check one reason
    text
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1882120 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    If no informed consent has been obtained, check one reason
    Code List
    If no informed consent has been obtained, check one reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    Item
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    If a request has been made for sample destruction, check one reason
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    If a request has been made for sample destruction, check one reason
    Code List
    If a request has been made for sample destruction, check one reason
    CL Item
    Subject requested (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (Z)
    If other reason for request for sample destruction, specify
    Item
    If other reason for request for sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Were any concomitant medications taken by the subject during the study?
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Unit Dose
    Item
    Unit Dose
    float
    C0869039 (UMLS CUI [1])
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Units
    Code List
    Units
    CL Item
    Tablet (TAB)
    CL Item
    Microlitre (MCL)
    CL Item
    Millilitre (ML)
    CL Item
    Litre (L)
    CL Item
    Microgram (MCG)
    CL Item
    Milligram (MG)
    CL Item
    Gram (G)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
    1 x Daily (OD/QD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily (QID)
    CL Item
    As required (PRN)
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Topical (TP)
    CL Item
    Oral (PO)
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication Start Date
    Item
    Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Medication Start Time
    Item
    Medication Start Time
    time
    C2826734 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Medication taken prior to study?
    Item
    Medication taken prior to study?
    boolean
    C2826667 (UMLS CUI [1])
    Medication Stop Date
    Item
    Medication Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication Stop Time
    Item
    Medication Stop Time
    time
    C2826659 (UMLS CUI [1])
    Ongoing Medication?
    Item
    Ongoing Medication?
    boolean
    C2826666 (UMLS CUI [1])
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