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ID

37324

Beskrivning

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This 12 lead ECG form is to be completed at Screening, Day 2/3/4 at 0 hrs for all cohorts (Day 4 0 hrs denoted as Day 3 24 hrs), Follow-Up and for any repeat/unscheduled ECGs.

Länk

https://clinicaltrials.gov/ct2/show/NCT00996840

Nyckelord

Versioner (1)
  1. 17/07/19 17/07/19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 luglio 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    Engelsk

    12 Lead ECG

    1 Formulär  
    1. StudyEvent: ODM
      1. 12 Lead ECG
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject ID
    Beskrivning

    Subject ID

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Type of Visit
    Beskrivning

    Type of Visit

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3641100
    Dosing Date and Time
    Beskrivning

    Dosing Date and Time

    Alias
    UMLS CUI-1
    C3897500
    UMLS CUI-2
    C3469597
    UMLS CUI-3
    C0304229
    Start Dosing date/time
    Beskrivning

    only applicable for ECGs during medication days (Day 2, Day 3, Repeat), not for Screening and Follow-Up

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C3897500
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0304229
    ECG
    Beskrivning

    ECG

    Alias
    UMLS CUI-1
    C1623258
    Time after start dose
    Beskrivning

    only applicable for scheduled ECGs on Day 2 (0 hrs) and Day 3 (0 hrs, 24 hrs)

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C3897500
    UMLS CUI [1,4]
    C3469597
    UMLS CUI [1,5]
    C0304229
    Date and Time of ECG
    Beskrivning

    ECG Date / Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart Rate
    Beskrivning

    Heart Rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Beskrivning

    PR Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Beskrivning

    QRS Duration

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Beskrivning

    Uncorrected QT Interval

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C1287082
    UMLS CUI [1,2]
    C4072785
    msec
    Method of QTC Calculation
    Beskrivning

    If Machine -> record the QTC values(s) generated by the machine (QTcF/QTcB) If Manual -> record the RR interval that precedes the measured QT interval

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    QTCB Interval
    Beskrivning

    if applicable

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C1882512
    UMLS CUI [1,2]
    C0855331
    msec
    QTCF Interval
    Beskrivning

    if applicable

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C1882513
    msec
    record the RR interval that precedes the measured QT interval:
    Beskrivning

    if applicable

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1,1]
    C0489636
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0855331
    msec
    Result of the ECG
    Beskrivning

    if 3 = Abnormal - Clinically significant: complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Tillbaka till toppen

    Similar models

    12 Lead ECG

    1 Formulär
    1. StudyEvent: ODM
      1. 12 Lead ECG
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    integer
    C3641100 (UMLS CUI [1])
    Type of Visit
    Code List
    Type of Visit
    CL Item
    Screening (1)
    CL Item
    Day 2 (2)
    CL Item
    Day 3 (3)
    CL Item
    Follow-up (4)
    CL Item
    Repeat Assessment (5)
    Item Group
    Dosing Date and Time
    C3897500 (UMLS CUI-1)
    C3469597 (UMLS CUI-2)
    C0304229 (UMLS CUI-3)
    Start Dosing date/time
    Item
    Start Dosing date/time
    datetime
    C3897500 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Item Group
    ECG
    C1623258 (UMLS CUI-1)
    Item
    Time after start dose
    integer
    C0439564 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C3897500 (UMLS CUI [1,3])
    C3469597 (UMLS CUI [1,4])
    C0304229 (UMLS CUI [1,5])
    Time after start dose
    Code List
    Time after start dose
    CL Item
    0 hr (1)
    CL Item
    24 hr (2)
    ECG Date / Time
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    float
    C1287082 (UMLS CUI [1,1])
    C4072785 (UMLS CUI [1,2])
    Item
    Method of QTC Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Method of QTC Calculation
    Code List
    Method of QTC Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    QTCB Interval
    Item
    QTCB Interval
    float
    C1882512 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    QTCF Interval
    Item
    QTCF Interval
    float
    C0855331 (UMLS CUI [1,1])
    C1882513 (UMLS CUI [1,2])
    manual QTc: RR interval
    Item
    record the RR interval that precedes the measured QT interval:
    float
    C0489636 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0855331 (UMLS CUI [1,3])
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    ECG Result
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
    Tillbaka till toppen 

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