0 Ratings
ID

37354

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 contains details on the administration of the investigational product and is to be filled in at Day 1, 2 and 3. Additionally, this form also contains Randomisation information and the assignment of the participant to one of the four cohorts for/prior to the first medication administration.

Link

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

Keywords

Versions (2)
  1. 7/16/19 7/16/19 -
  2. 7/20/19 7/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 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

    Investigational Product - IV Dosing, Randomisation, Cohort Assignment

    1 forms  
    Administrative Data
    Description

    Administrative Data

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

    Subject ID

    Data type

    integer

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

    please fill in the form for each of the three study days

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Which Cohort is the subject enrolled in?
    Description

    Please ensure the Cohort selected is correct before submitting. Medication is infused over 4 or 24 hours depending on the cohort.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0599755 (Cohort)
    Date/Time of Cohort Assignment
    Description

    Date/Time of Cohort Assignment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0599755 (Cohort)
    UMLS CUI [1,2]
    C1516050 (Assignment - action)
    SNOMED
    4561000175109
    UMLS CUI [1,3]
    C1264639 (Date/Time)
    SNOMED
    118575009
    First Administration
    Description

    First Administration

    Alias
    UMLS CUI-1
    C3469597 (Administration of medication)
    SNOMED
    18629005
    Dosage Duration (per Protocol)
    Description

    Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24hrs

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,2]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    Start Date and Time
    Description

    Start Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C3897500 (Start Date and Time of Procedure)
    Stop Date and Time
    Description

    Stop Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C3899266 (End Date and Time of Procedure)
    Volume administered (mL)
    Description

    Volume administered

    Data type

    float

    Measurement units
    • mL
    Alias
    UMLS CUI [1]
    C2349139 (Volume Administered)
    mL
    Administration post interruption
    Description

    Administration post interruption

    Alias
    UMLS CUI-1
    C3469597 (Administration of medication)
    SNOMED
    18629005
    UMLS CUI-2
    C0687676 (Post)
    SNOMED
    288563008
    LOINC
    LP20512-7
    UMLS CUI-3
    C1512900 (Interruption)
    Dosage Duration (per Protocol)
    Description

    Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24 hrs

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,2]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    Start Date and Time
    Description

    Start Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C3897500 (Start Date and Time of Procedure)
    Stop Date and Time
    Description

    Stop Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C3899266 (End Date and Time of Procedure)
    Volume administered (mL)
    Description

    Volume administered

    Data type

    float

    Measurement units
    • mL
    Alias
    UMLS CUI [1]
    C2349139 (Volume Administered)
    mL
    Investigational Product Container Number
    Description

    Investigational Product Container Number

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI-3
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Investigational Product Container Number
    Description

    Record the identifying number from the investigational product container dispensed at this visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI [1,3]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Treatment Confirmation
    Description

    Treatment Confirmation

    Alias
    UMLS CUI-1
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    UMLS CUI-2
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Description

    If no, record reasons

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C2349182 (Correct (qualifier))
    LOINC
    LA9960-1
    Reason incorrect treatment
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,3]
    C3827420 (Wrong)
    LOINC
    LA7342-4
    Randomisation Number
    Description

    Randomisation Number

    Alias
    UMLS CUI-1
    C0034656 (Randomization)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Was the subject able to be randomised?
    Description

    If yes, provide Randomisation Number and Date/time of randomisation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0332149 (Possible)
    SNOMED
    371930009
    LOINC
    LA15097-1
    Randomisation Number
    Description

    if applicable

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Date/time of randomisation
    Description

    if applicable

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
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    Similar models

    Investigational Product - IV Dosing, Randomisation, Cohort Assignment

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item
    Date of Visit
    integer
    C1320303 (UMLS CUI [1])
    Date of Visit
    Code List
    Date of Visit
    CL Item
    Day 1 (1)
    CL Item
    Day 2 (2)
    CL Item
    Day 3 (3)
    Item
    Which Cohort is the subject enrolled in?
    text
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Which Cohort is the subject enrolled in?
    CL Item
    Cohort 1 (3mg/Placebo IV / 4hrs) (C1)
    CL Item
    Cohort 2 (7.5mg/Placebo IV / 24hrs) (C2)
    CL Item
    Cohort 3 (7.5mg/Placebo IV / 4hrs) (C3)
    CL Item
    Cohort 4 (10mg/Placebo IV / 24hrs) (C4)
    Date/Time of Cohort Assignment
    Item
    Date/Time of Cohort Assignment
    datetime
    C0599755 (UMLS CUI [1,1])
    C1516050 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Item Group
    First Administration
    C3469597 (UMLS CUI-1)
    Item
    Dosage Duration (per Protocol)
    integer
    C0449238 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Dosage Duration
    Code List
    Dosage Duration (per Protocol)
    CL Item
    0-4 hrs (1)
    CL Item
    0-24 hrs (2)
    Start Date and Time
    Item
    Start Date and Time
    datetime
    C3897500 (UMLS CUI [1])
    Stop Date and Time
    Item
    Stop Date and Time
    datetime
    C3899266 (UMLS CUI [1])
    Volume administered
    Item
    Volume administered (mL)
    float
    C2349139 (UMLS CUI [1])
    Item Group
    Administration post interruption
    C3469597 (UMLS CUI-1)
    C0687676 (UMLS CUI-2)
    C1512900 (UMLS CUI-3)
    Item
    Dosage Duration (per Protocol)
    integer
    C0449238 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Dosage Duration
    Code List
    Dosage Duration (per Protocol)
    CL Item
    0-4 hrs (1)
    CL Item
    0-24 hrs (2)
    Start Date and Time
    Item
    Start Date and Time
    datetime
    C3897500 (UMLS CUI [1])
    Stop Date and Time
    Item
    Stop Date and Time
    datetime
    C3899266 (UMLS CUI [1])
    Volume administered
    Item
    Volume administered (mL)
    float
    C2349139 (UMLS CUI [1])
    Item Group
    Investigational Product Container Number
    C0304229 (UMLS CUI-1)
    C0180098 (UMLS CUI-2)
    C0600091 (UMLS CUI-3)
    Investigational Product Container Number
    Item
    Investigational Product Container Number
    text
    C0304229 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Item Group
    Treatment Confirmation
    C0750484 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Correct treatment received
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    Reason incorrect treatment
    Item
    Reason incorrect treatment
    text
    C0566251 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C3827420 (UMLS CUI [1,3])
    Item Group
    Randomisation Number
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Randomisation possible
    Item
    Was the subject able to be randomised?
    boolean
    C0034656 (UMLS CUI [1,1])
    C0332149 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Randomisation Date/Time
    Item
    Date/time of randomisation
    datetime
    C0034656 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
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