0 Ratings
ID

37641

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 results relating to the coagulation system and lung epithelial cell injury, taken repeatedly on Day 1 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 13, 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 Results

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Type of Visit
    Description

    Results should be filled in for all of the following scheduled samples (time relative to the start of dose). This is identical for all cohorts. Select option 8 for repeat/unscheduled assessments.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Cohort
    Description

    Cohort

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Pharmacodynamics Results
    Description

    Pharmacodynamics Results

    Alias
    UMLS CUI-1
    C0851347
    UMLS CUI-2
    C1254595
    Start Dosing date/time
    Description

    [read-only]

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C3897500
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0178602
    Actual date/time
    Description

    Sample date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [1,3]
    C0031328
    INR Result Type
    Description

    INR Result Type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0525032
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0332307
    INR Numeric Result
    Description

    if applicable

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2347373
    UMLS CUI [1,2]
    C0525032
    INR text result
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C2350015
    UMLS CUI [1,3]
    C0525032
    PT Result Type
    Description

    PT Result Type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C0491338
    PT Numeric Result
    Description

    if applicable

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2347373
    UMLS CUI [1,2]
    C0491338
    PT text result
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C2350015
    UMLS CUI [1,3]
    C0491338
    PTT Result Type
    Description

    PTT Result Type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030605
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0332307
    PTT Numeric Result
    Description

    if applicable

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C2347373
    UMLS CUI [1,2]
    C0030605
    PTT text result
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C2350015
    UMLS CUI [1,3]
    C0030605
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    Similar models

    Pharmacodynamics Results

    1 forms
    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 3 - 0 hr (5)
    CL Item
    Day 3 - 24 hr (6)
    CL Item
    Day 3 - 48 hr (7)
    CL Item
    Repeat Sampling (8)
    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 Results
    C0851347 (UMLS CUI-1)
    C1254595 (UMLS CUI-2)
    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])
    Item
    INR Result Type
    integer
    C0525032 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    INR Result Type
    Code List
    INR Result Type
    CL Item
    Numeric result (98)
    CL Item
    Text result (99)
    INR Numeric Result
    Item
    INR Numeric Result
    float
    C2347373 (UMLS CUI [1,1])
    C0525032 (UMLS CUI [1,2])
    INR text result
    Item
    INR text result
    text
    C1274040 (UMLS CUI [1,1])
    C2350015 (UMLS CUI [1,2])
    C0525032 (UMLS CUI [1,3])
    Item
    PT Result Type
    integer
    C1274040 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C0491338 (UMLS CUI [1,3])
    INR Result Type
    Code List
    PT Result Type
    CL Item
    Numeric result (98)
    CL Item
    Text result (99)
    PT Numeric Result
    Item
    PT Numeric Result
    float
    C2347373 (UMLS CUI [1,1])
    C0491338 (UMLS CUI [1,2])
    PT text result
    Item
    PT text result
    text
    C1274040 (UMLS CUI [1,1])
    C2350015 (UMLS CUI [1,2])
    C0491338 (UMLS CUI [1,3])
    Item
    PTT Result Type
    integer
    C0030605 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    INR Result Type
    Code List
    PTT Result Type
    CL Item
    Numeric result (98)
    CL Item
    Text result (99)
    PTT Numeric Result
    Item
    PTT Numeric Result
    float
    C2347373 (UMLS CUI [1,1])
    C0030605 (UMLS CUI [1,2])
    PTT text result
    Item
    PTT text result
    text
    C1274040 (UMLS CUI [1,1])
    C2350015 (UMLS CUI [1,2])
    C0030605 (UMLS CUI [1,3])
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