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ID

38810

Beschrijving

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

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  1. 05-11-19 05-11-19 -
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GlaxoSmithKline

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5 november 2019

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Creative Commons BY-NC 3.0
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    Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

    Engels

    Investigational Product (Period 1 - 5; Day 1 - Day 16)

    1 Formulieren  
    Investigational Product (Dose) (Period 1 - 5)
    Beschrijving

    Investigational Product (Dose) (Period 1 - 5)

    Date/ time of dose
    Beschrijving

    Date/ time of dose

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [2,1]
    C0178602
    UMLS CUI [2,2]
    C0011008
    Number of Actuations
    Beschrijving

    Number of Actuations

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C4055499
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschrijving

    Did the subject receive the correct treatment during this dosing interval?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Beschrijving

    If the subject did not receive the correct treatment during this dosing interval, record reasons.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0392360
    Investigational Product (Dose) (Day 1 - 13)
    Beschrijving

    Investigational Product (Dose) (Day 1 - 13)

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0178602
    Dose Timepoint
    Beschrijving

    Dose Timepoint

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C2348792
    Start date/time of dose
    Beschrijving

    Start date/time of dose

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C1301880
    UMLS CUI [2,2]
    C0178602
    Number of Actuations
    Beschrijving

    Number of Actuations

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C4055499
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschrijving

    Did the subject receive the correct treatment during this dosing interval?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Beschrijving

    If the subject did not receive the correct treatment during this dosing interval, record reasons.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0392360
    Investigational Product (Day 3 - Day 13 Dose)
    Beschrijving

    Investigational Product (Day 3 - Day 13 Dose)

    Alias
    UMLS CUI-1
    C0304229
    Dose Timepoint
    Beschrijving

    Dose Timepoint

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348792
    UMLS CUI [1,2]
    C2348792
    Start date/time of dose
    Beschrijving

    Start date/time of dose

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C1301880
    UMLS CUI [2,2]
    C0178602
    Number of Actuations
    Beschrijving

    Number of Actuations

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C4055499
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschrijving

    Did the subject receive the correct treatment during this dosing interval?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Beschrijving

    If the subject did not receive the correct treatment during this dosing interval, record reasons.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0392360
    Investigational Product (Dose) (Day 14 - 16)
    Beschrijving

    Investigational Product (Dose) (Day 14 - 16)

    Alias
    UMLS CUI-1
    C0304229
    Dose Timepoint
    Beschrijving

    Dose Timepoint

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348792
    UMLS CUI [1,2]
    C2348792
    Start date/time of dose
    Beschrijving

    Start date/time of dose

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2,1]
    C1301880
    UMLS CUI [2,2]
    C0178602
    Number of Actuations
    Beschrijving

    Number of Actuations

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C4055499
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschrijving

    Did the subject receive the correct treatment during this dosing interval?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Beschrijving

    If the subject did not receive the correct treatment during this dosing interval, record reasons.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0392360
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    Similar models

    Investigational Product (Period 1 - 5; Day 1 - Day 16)

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Investigational Product (Dose) (Period 1 - 5)
    Date/ time of dose
    Item
    Date/ time of dose
    datetime
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Number of Actuations
    Item
    Number of Actuations
    integer
    C4055499 (UMLS CUI [1])
    Did the subject receive the correct treatment during this dosing interval?
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Item
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Investigational Product (Dose) (Day 1 - 13)
    C0304229 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    Item
    Dose Timepoint
    integer
    C0178602 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Dose Timepoint
    Code List
    Dose Timepoint
    CL Item
    Day 1 AM dose (1)
    CL Item
    Day 1 PM dose (2)
    CL Item
    Day 2 AM dose (3)
    CL Item
    Day 2 PM dose (4)
    Start date/time of dose
    Item
    Start date/time of dose
    datetime
    C0808070 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Number of Actuations
    Item
    Number of Actuations
    integer
    C4055499 (UMLS CUI [1])
    Did the subject receive the correct treatment during this dosing interval?
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Item
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Investigational Product (Day 3 - Day 13 Dose)
    C0304229 (UMLS CUI-1)
    Item
    Dose Timepoint
    integer
    C2348792 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Timepoint
    Code List
    Dose Timepoint
    CL Item
    Day 3 AM (1)
    CL Item
    Day 3 PM (2)
    CL Item
    Day 4 AM (3)
    CL Item
    Day 4 PM (4)
    CL Item
    Day 5 AM (5)
    CL Item
    Day 5 PM (6)
    CL Item
    Day 6 AM (7)
    CL Item
    Day 6 PM (8)
    CL Item
    Day 7 AM (9)
    CL Item
    Day 7 PM (10)
    CL Item
    Day 8 AM (11)
    CL Item
    Day 8 PM (12)
    CL Item
    Day 9 AM (13)
    CL Item
    Day 9 PM (14)
    CL Item
    Day 10 AM (15)
    CL Item
    Day 10 PM (16)
    CL Item
    Day 11 AM (17)
    CL Item
    Day 11PM (18)
    CL Item
    Day 12 AM (19)
    CL Item
    Day 12 PM (20)
    CL Item
    Day 13 AM (21)
    CL Item
    Day 13 PM (22)
    Start date/time of dose
    Item
    Start date/time of dose
    datetime
    C0808070 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Number of Actuations
    Item
    Number of Actuations
    integer
    C4055499 (UMLS CUI [1])
    Did the subject receive the correct treatment during this dosing interval?
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Item
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Investigational Product (Dose) (Day 14 - 16)
    C0304229 (UMLS CUI-1)
    Item
    Dose Timepoint
    integer
    C2348792 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Dose Timepoint
    Code List
    Dose Timepoint
    CL Item
    Day 14 AM dose (1)
    CL Item
    Day 14 PM dose (2)
    Start date/time of dose
    Item
    Start date/time of dose
    datetime
    C0808070 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    Number of Actuations
    Item
    Number of Actuations
    integer
    C4055499 (UMLS CUI [1])
    Did the subject receive the correct treatment during this dosing interval?
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    Item
    If the subject did not receive the correct treatment during this dosing interval, record reasons.
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
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