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ID

37357

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 in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Link

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

Stichworte

Versionen (2)
  1. 20.07.19 20.07.19 -
  2. 17.09.21 17.09.21 -
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

    Logs and Repeats

    1 Formulare  
    1. StudyEvent: ODM
      1. Logs and Repeats
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date/time of visit/assessment
    Beschreibung

    Date/time of visit/assessment

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1264639
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [2,1]
    C1264639
    UMLS CUI [2,2]
    C1516048
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
    Beschreibung

    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-3
    C2347852
    UMLS CUI-5
    C0205341
    UMLS CUI-6
    C0220825
    Did the subject experience any non-serious adverse events during the study?
    Beschreibung

    non-serious adverse events

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Did the subject experience any serious adverse events during the study?
    Beschreibung

    serious adverse events

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Were any concomitant medications taken by the subject during the study?
    Beschreibung

    concomitant medication

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
    Beschreibung

    blood products

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0456388
    UMLS CUI [2,1]
    C0456388
    UMLS CUI [2,2]
    C0344211
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    Beschreibung

    abnormal, clinically significant ECG

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1832603
    UMLS CUI [1,2]
    C2985739
    Were any repeat ECGs performed?
    Beschreibung

    repeat ECGs

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0205341
    Were any repeat haematology or clinical chemistry samples taken during the study?
    Beschreibung

    repeat haematology or clinical chemistry samples taken

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [2,1]
    C0018941
    UMLS CUI [2,2]
    C0200345
    UMLS CUI [2,3]
    C0205341
    Were any repeat urinalysis samples taken?
    Beschreibung

    repeat urinalysis samples

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0205341
    UMLS CUI [1,3]
    C0042014
    Were any repeat Blood pharmacodynamic samples taken for external analysis?
    Beschreibung

    repeat Blood pharmacodynamic samples taken for external analysis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C1277698
    UMLS CUI [1,3]
    C3844314
    UMLS CUI [1,4]
    C0851347
    Were any repeat Urine pharmacodynamic samples taken for external analysis?
    Beschreibung

    repeat urine pharmacodynamic samples taken for external analysis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C0200354
    UMLS CUI [1,3]
    C3844314
    UMLS CUI [1,4]
    C0851347
    Were any repeat pharmocodynamic samples taken for analysis at site?
    Beschreibung

    repeat pharmocodynamic samples taken for analysis at site

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0851347
    UMLS CUI [1,4]
    C2825164
    Were any repeat pharmacokinetic samples taken?
    Beschreibung

    repeat pharmacokinetic samples

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0031328
    Were any repeat vital signs recorded?
    Beschreibung

    repeat vital signs

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205341
    UMLS CUI [1,2]
    C0518766
    Liver Event
    Beschreibung

    Liver Event

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Beschreibung

    If yes, please complete the Liver Event form(s).

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023901
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [1,3]
    C0243161
    UMLS CUI [1,4]
    C2746065
    UMLS CUI [1,5]
    C0304229
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    Ähnliche Modelle

    Logs and Repeats

    1 Formulare
    1. StudyEvent: ODM
      1. Logs and Repeats
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date/time of visit/assessment
    Item
    Date/time of visit/assessment
    datetime
    C1264639 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [2,1])
    C1516048 (UMLS CUI [2,2])
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-3)
    C0205341 (UMLS CUI-5)
    C0220825 (UMLS CUI-6)
    non-serious adverse events
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    serious adverse events
    Item
    Did the subject experience any serious adverse events during the study?
    boolean
    C1519255 (UMLS CUI [1])
    concomitant medication
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    blood products
    Item
    Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
    boolean
    C0456388 (UMLS CUI [1])
    C0456388 (UMLS CUI [2,1])
    C0344211 (UMLS CUI [2,2])
    abnormal, clinically significant ECG
    Item
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    boolean
    C1832603 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    repeat ECGs
    Item
    Were any repeat ECGs performed?
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    repeat haematology or clinical chemistry samples taken
    Item
    Were any repeat haematology or clinical chemistry samples taken during the study?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    C0205341 (UMLS CUI [2,3])
    repeat urinalysis samples
    Item
    Were any repeat urinalysis samples taken?
    boolean
    C0200345 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C0042014 (UMLS CUI [1,3])
    repeat Blood pharmacodynamic samples taken for external analysis
    Item
    Were any repeat Blood pharmacodynamic samples taken for external analysis?
    boolean
    C0205341 (UMLS CUI [1,1])
    C1277698 (UMLS CUI [1,2])
    C3844314 (UMLS CUI [1,3])
    C0851347 (UMLS CUI [1,4])
    repeat urine pharmacodynamic samples taken for external analysis
    Item
    Were any repeat Urine pharmacodynamic samples taken for external analysis?
    boolean
    C0205341 (UMLS CUI [1,1])
    C0200354 (UMLS CUI [1,2])
    C3844314 (UMLS CUI [1,3])
    C0851347 (UMLS CUI [1,4])
    repeat pharmocodynamic samples taken for analysis at site
    Item
    Were any repeat pharmocodynamic samples taken for analysis at site?
    boolean
    C0205341 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0851347 (UMLS CUI [1,3])
    C2825164 (UMLS CUI [1,4])
    repeat pharmacokinetic samples
    Item
    Were any repeat pharmacokinetic samples taken?
    boolean
    C0205341 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0031328 (UMLS CUI [1,3])
    repeat vital signs
    Item
    Were any repeat vital signs recorded?
    boolean
    C0205341 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Item Group
    Liver Event
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    liver chemistry results reached/exceeded investigational product stopping criteria
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0023901 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0243161 (UMLS CUI [1,3])
    C2746065 (UMLS CUI [1,4])
    C0304229 (UMLS CUI [1,5])
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