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ID

37373

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 is to be filled with data regarding pharmacokinetic samples, taken repeatedly on Day 1, 2 and 3 (times vary depending on cohort), and can also be used for repeat analyses.

Link

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

Stichworte

Versionen (1)
  1. 20.07.19 20.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. 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

    Pharmacokinetics Blood

    1 Formulare  
    1. StudyEvent: ODM
      1. Pharmacokinetics Blood
    Administrative Data
    Beschreibung

    Administrative Data

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

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date/Time of Assessment
    Beschreibung

    Date/Time of Assessment

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720 (Assessment Date)
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Type of Visit
    Beschreibung

    Type of Visit

    Datentyp

    integer

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

    Times of sampling vary depending on cohort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0599755 (Cohort)
    Pharmacokinetics Blood
    Beschreibung

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Start Dosing date/time
    Beschreibung

    [read-only]

    Datentyp

    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
    Time After Dose
    Beschreibung

    Times of sampling varies depending on Cohort: For Cohorts 1/3: Cohorts 1/3 on Day 1: 0 hr, 4 hr, 4.25 hr, 5 hr, 8 hr, 12 hr. Cohorts 1/3 on Day 2: 0 hr. Cohorts 1/3 on Day 3: 0 hr, 24 hr. For Cohorts 2/4: Cohorts 2/4 on Day 1: 0 hr. Cohorts 2/4 on Day 2: 0 hr. Cohorts 2/4 on Day 3: 0 hr, 24 hr, 24 hr 10 min, 24 hr 45 min, 27 hr, 34 hr, 40 hr, 48 hr. In total, there are 9 samples collected for Cohorts 1 and 3, and 10 samples for Cohorts 2 and 4. This item is not required for Repeat Pharmacokinetics

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0439568 (Post-dose)
    SNOMED
    255566006
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    Actual date/time
    Beschreibung

    Sample date/time

    Datentyp

    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)
    PK Sample ID
    Beschreibung

    for Repeat Pharmacokinetics only

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    UMLS CUI [1,2]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Pharmacokinetics Blood

    1 Formulare
    1. StudyEvent: ODM
      1. Pharmacokinetics Blood
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    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 (1)
    CL Item
    Day 2 (2)
    CL Item
    Day 3 (3)
    CL Item
    Repeat Sampling (4)
    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
    Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (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])
    Item
    Time After Dose
    integer
    C0040223 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Time After Dose
    Code List
    Time After Dose
    CL Item
    0 hr (1)
    CL Item
    4 hr (2)
    CL Item
    4.25 hr (3)
    CL Item
    5 hr (4)
    CL Item
    8 hr (5)
    CL Item
    12 hr (6)
    CL Item
    24 hr (7)
    CL Item
    24 hr 10 min (8)
    CL Item
    24 hr 45 min (9)
    CL Item
    27 hr (10)
    CL Item
    34 hr (11)
    CL Item
    40 hr (12)
    CL Item
    48 hr (13)
    Sample date/time
    Item
    Actual date/time
    datetime
    C0200345 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0031328 (UMLS CUI [1,3])
    PK Sample ID
    Item
    PK Sample ID
    text
    C1299222 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
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