ID

37368

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 data on the participant's initial trauma, and is to be filled in at Screening.

Link

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

Keywords

  1. 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

  1. StudyEvent: ODM
    1. Trauma
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Trauma
Description

Trauma

Alias
UMLS CUI-1
C3714660
Date and approx. time of Trauma
Description

Date/Time of Trauma

Data type

datetime

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C1264639
Date/time of Hospitalisation
Description

Date/time of Hospitalisation

Data type

datetime

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1264639
Glasgow Coma Scale
Description

Glasgow Coma Scale

Alias
UMLS CUI-1
C1271007
Glasgow Coma Scale (total score)
Description

Glasgow Coma Scale

Data type

integer

Alias
UMLS CUI [1]
C1271007
Injury Severity Score
Description

Injury Severity Score

Alias
UMLS CUI-1
C0021504
Injury Severity Score (total score)
Description

Injury Severity Score

Data type

integer

Alias
UMLS CUI [1]
C0021504

Similar models

Trauma

  1. StudyEvent: ODM
    1. Trauma
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])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Trauma
C3714660 (UMLS CUI-1)
Date/Time of Trauma
Item
Date and approx. time of Trauma
datetime
C3263723 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Date/time of Hospitalisation
Item
Date/time of Hospitalisation
datetime
C0019993 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Glasgow Coma Scale
C1271007 (UMLS CUI-1)
Glasgow Coma Scale
Item
Glasgow Coma Scale (total score)
integer
C1271007 (UMLS CUI [1])
Item Group
Injury Severity Score
C0021504 (UMLS CUI-1)
Injury Severity Score
Item
Injury Severity Score (total score)
integer
C0021504 (UMLS CUI [1])

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