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ID

37320

Beschreibung

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 includes Clinical Chemistry and Haematology lab examinations and results and is to be filled in at Screening, on Days 2 and 3 at 0 hrs and Day 3 at 24 hrs (i.e. Day 4 - 0 hrs) and at Follow-Up for all cohorts and for any repeat analyses.

Link

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

Stichworte

Versionen (1)
  1. 16.07.19 16.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Juli 2019

DOI

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Lizenz

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

    Englisch

    Local Laboratory - Clinical Chemistry and Haematology

    1 Formulare  
    Laboratory Administrative Data
    Beschreibung

    Laboratory Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    UMLS CUI-2
    C0022885
    Type of Visit
    Beschreibung

    Type of Visit

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3641100
    Planned Date/Time of Sample
    Beschreibung

    if applicable on respective Day (Day 2 or 3)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1264639
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1301732
    Date and time sample taken
    Beschreibung

    Date/Time of Sample

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1264639
    UMLS CUI [1,2]
    C0200345
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Has the subject fasted?
    Beschreibung

    Fasting

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    Clinical Chemistry Analysis
    Beschreibung

    Clinical Chemistry Analysis

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0022885
    Clinical chemistry lab test
    Beschreibung

    Fill in the following items for each analysed feature at all visits (except for repeat assessments). The following items are not mandatory for Days 2 and 3 for all cohorts: 16 = Prothrombin Time (PT) 17 = Partial Thromboplastin Time (PTT) 19 = International normalized ratio (INR) 22 = Arterial Blood pH 23 = Serum Estradiol item 22 = Arterial Blood pH is not mandatory for Follow-up Select the appropriate feature for Repeat Analysis. The inclusion of 23 = Serum Estradiol during Screening and Follow-Up is a change to the study.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0022885
    Clinical chemistry result type
    Beschreibung

    Clinical chemistry result type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0332307
    Clinical chemistry numeric result
    Beschreibung

    if applicable

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C2347373
    Clinical chemistry character result
    Beschreibung

    if applicable

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C2350015
    Haematology Lab Analysis
    Beschreibung

    Haematology Lab Analysis

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0018941
    Haematology Lab test
    Beschreibung

    Select the appropriate feature for Repeat Analysis At all other visits, fill in the following items for each analysed feature.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0018941
    Haematology Lab result type
    Beschreibung

    Haematology Lab result type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0018941
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C0332307
    Haematology Lab numeric result
    Beschreibung

    if applicable

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C2347373
    Haematology Lab character result
    Beschreibung

    if applicable

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C2350015
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Local Laboratory - Clinical Chemistry and Haematology

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Laboratory Administrative Data
    C1320722 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    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
    Planned Date/Time of Sample
    integer
    C1264639 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Planned Date/Time of Sample
    Code List
    Planned Date/Time of Sample
    CL Item
    0 hrs (1)
    CL Item
    24 hrs (2)
    Date/Time of Sample
    Item
    Date and time sample taken
    datetime
    C1264639 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Fasting
    Item
    Has the subject fasted?
    boolean
    C0015663 (UMLS CUI [1])
    Item Group
    Clinical Chemistry Analysis
    C0008000 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Item
    Clinical chemistry lab test
    integer
    C0008000 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Clinical chemistry lab test
    Code List
    Clinical chemistry lab test
    CL Item
    Alanine aminotransferase (ALT/SGPT) (1)
    CL Item
    Aspartate aminotransferase (AST/SGOT) (2)
    CL Item
    Total Bilirubin (3)
    CL Item
    Direct Bilirubin (4)
    CL Item
    Blood urea nitrogen (BUN) (5)
    CL Item
    Glucose (6)
    CL Item
    Gamma glutamyltransferase (GGT) (7)
    CL Item
    Total Protein (8)
    CL Item
    Albumin (9)
    CL Item
    Potassium (10)
    CL Item
    Sodium (11)
    CL Item
    Calcium (12)
    CL Item
    Chloride (13)
    CL Item
    Total CO2 (14)
    CL Item
    Creatinine (15)
    CL Item
    Prothrombin Time (PT) (16)
    CL Item
    Partial Thromboplastin Time (PTT) (17)
    CL Item
    Creatinine Kinase (CK) (18)
    CL Item
    International normalized ratio (INR) (19)
    CL Item
    Uric Acid (20)
    CL Item
    Alkaline Phosphatase (21)
    CL Item
    Arterial Blood pH (22)
    CL Item
    Serum Estradiol (23)
    Item
    Clinical chemistry result type
    integer
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Clinical chemistry result type
    Code List
    Clinical chemistry result type
    CL Item
    Numeric result (97)
    CL Item
    Character result (98)
    CL Item
    No result (99)
    Clinical chemistry numeric result
    Item
    Clinical chemistry numeric result
    float
    C0008000 (UMLS CUI [1,1])
    C2347373 (UMLS CUI [1,2])
    Clinical chemistry character result
    Item
    Clinical chemistry character result
    text
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C2350015 (UMLS CUI [1,3])
    Item Group
    Haematology Lab Analysis
    C0022885 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Item
    Haematology Lab test
    integer
    C0022885 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Haematology Lab test
    Code List
    Haematology Lab test
    CL Item
    RBC (1)
    CL Item
    Reticulocytes (2)
    CL Item
    Haemoglobin (3)
    CL Item
    MCV (4)
    CL Item
    MCH (5)
    CL Item
    MCHC (6)
    CL Item
    WBC (7)
    CL Item
    Neutrophils (8)
    CL Item
    Lymphocytes (9)
    CL Item
    Monocytes (10)
    CL Item
    Eosinophils (11)
    CL Item
    Basophils (12)
    CL Item
    Platelets (13)
    Item
    Haematology Lab result type
    integer
    C0022885 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0332307 (UMLS CUI [1,4])
    Haematology Lab result type
    Code List
    Haematology Lab result type
    CL Item
    Numeric result (97)
    CL Item
    Character result (98)
    CL Item
    No result (99)
    Haematology Lab numeric result
    Item
    Haematology Lab numeric result
    float
    C0018941 (UMLS CUI [1,1])
    C2347373 (UMLS CUI [1,2])
    Haematology Lab character result
    Item
    Haematology Lab character result
    text
    C0018941 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C2350015 (UMLS CUI [1,3])
    Zum Seitenanfang zurückkehren 

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