0 Ratings
ID

37673

Description

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 form is to be filled with data regarding pharmacodynamic samples, taken repeatedly on Day 1, 2 and 3, and can also be used for repeat analyses.

Link

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

Keywords

Versions (2)
  1. 8/13/19 8/13/19 -
  2. 8/15/19 8/15/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

August 15, 2019

DOI

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License

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

    English

    Pharmacodynamics

    1 forms  
    1. StudyEvent: ODM
      1. Pharmacodynamics
    Administrative Data
    Description

    Administrative Data

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

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Type of Visit
    Description

    For scheduled visits, select options 1 to 8. The following samples have to be collected at these times: Day 1 - 0 hr: Blood, Flow Cytometry and Urine. Day 1 - 6 hr: Blood. Day 1 - 12 hr: Blood. Day 1 - 18 hr: Blood. Day 2 - 0 hr: Blood and Urine. Day 3 - 0 hr: Blood and Urine. Day 3 - 24 hr: Blood, Flow Cytometry and Urine. Day 3 - 48 hr: Blood. This is identical for all cohorts. For repeat assessments, select option 9, and chose the appropriate sample type.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Cohort
    Description

    Cohort

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0599755 (Cohort)
    Pharmacodynamics
    Description

    Pharmacodynamics

    Alias
    UMLS CUI-1
    C0851347 (Pharmacodynamics)
    Start Dosing date/time
    Description

    [read-only]

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C3897500 (Start Date and Time of Procedure)
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Actual date/time
    Description

    Sample date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    UMLS CUI [1,3]
    C0031328 (Pharmacokinetic aspects)
    Stop date/time of sample
    Description

    for Repeat Pharmacodynamics Urine only!

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [1,2]
    C3899266 (End Date and Time of Procedure)
    Sample Type
    Description

    Sample Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347029 (Biospecimen Type)
    PD Sample ID
    Description

    for Repeat Pharmacodynamics only

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    UMLS CUI [1,2]
    C0851347 (Pharmacodynamics)
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    Similar models

    Pharmacodynamics

    1 forms
    1. StudyEvent: ODM
      1. Pharmacodynamics
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Type of Visit
    Code List
    Type of Visit
    CL Item
    Day 1 - 0 hr (1)
    CL Item
    Day 1 - 6 hr (2)
    CL Item
    Day 1 - 12 hr (3)
    CL Item
    Day 1 - 18 hr (4)
    CL Item
    Day 2 - 0 hr (5)
    CL Item
    Day 3 - 0 hr (6)
    CL Item
    Day 3 - 24 hr (7)
    CL Item
    Day 3 - 48 hr (8)
    CL Item
    Repeat Sampling (9)
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Cohort
    CL Item
    Cohort 1 (1)
    CL Item
    Cohort 2 (2)
    CL Item
    Cohort 3 (3)
    CL Item
    Cohort 4 (4)
    Item Group
    Pharmacodynamics
    C0851347 (UMLS CUI-1)
    Start Dosing date/time
    Item
    Start Dosing date/time
    datetime
    C3897500 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Sample date/time
    Item
    Actual date/time
    datetime
    C0200345 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0031328 (UMLS CUI [1,3])
    Stop date/time of sample
    Item
    Stop date/time of sample
    text
    C0200345 (UMLS CUI [1,1])
    C3899266 (UMLS CUI [1,2])
    Item
    Sample Type
    integer
    C2347029 (UMLS CUI [1])
    Sample Type
    Code List
    Sample Type
    CL Item
    Blood (1)
    CL Item
    Urine (2)
    CL Item
    Flow Cytometry (3)
    PD Sample ID
    Item
    PD Sample ID
    text
    C1299222 (UMLS CUI [1,1])
    C0851347 (UMLS CUI [1,2])
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