ID

37368

Descrição

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

Palavras-chave

  1. 20/07/2019 20/07/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

20 de julho de 2019

DOI

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Licença

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
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

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

Date/Time of Assessment

Tipo de dados

datetime

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

Trauma

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

Date/Time of Trauma

Tipo de dados

datetime

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

Date/time of Hospitalisation

Tipo de dados

datetime

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

Glasgow Coma Scale

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

Glasgow Coma Scale

Tipo de dados

integer

Alias
UMLS CUI [1]
C1271007
Injury Severity Score
Descrição

Injury Severity Score

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

Injury Severity Score

Tipo de dados

integer

Alias
UMLS CUI [1]
C0021504

Similar models

  1. StudyEvent: ODM
    1. Trauma
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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