ID

37673

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 is to be filled with data regarding pharmacodynamic samples, taken repeatedly on Day 1, 2 and 3, and can also be used for repeat analyses.

Link

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

Keywords

  1. 8/13/19 8/13/19 -
  2. 8/15/19 8/15/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

August 15, 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

Pharmacodynamics

  1. StudyEvent: ODM
    1. Pharmacodynamics
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

For scheduled visits, select options 1 to 8. The following samples have to be collected at these times: Day 1 - 0 hr: Blood, Flow Cytometry and Urine. Day 1 - 6 hr: Blood. Day 1 - 12 hr: Blood. Day 1 - 18 hr: Blood. Day 2 - 0 hr: Blood and Urine. Day 3 - 0 hr: Blood and Urine. Day 3 - 24 hr: Blood, Flow Cytometry and Urine. Day 3 - 48 hr: Blood. This is identical for all cohorts. For repeat assessments, select option 9, and chose the appropriate sample type.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Pharmacodynamics
Description

Pharmacodynamics

Alias
UMLS CUI-1
C0851347
Start Dosing date/time
Description

[read-only]

Data type

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
Actual date/time
Description

Sample date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0031328
Stop date/time of sample
Description

for Repeat Pharmacodynamics Urine only!

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C3899266
Sample Type
Description

Sample Type

Data type

integer

Alias
UMLS CUI [1]
C2347029
PD Sample ID
Description

for Repeat Pharmacodynamics only

Data type

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0851347

Similar models

Pharmacodynamics

  1. StudyEvent: ODM
    1. Pharmacodynamics
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])
Item
Type of Visit
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of Visit
CL Item
Day 1 - 0 hr (1)
CL Item
Day 1 - 6 hr (2)
CL Item
Day 1 - 12 hr (3)
CL Item
Day 1 - 18 hr (4)
CL Item
Day 2 - 0 hr (5)
CL Item
Day 3 - 0 hr (6)
CL Item
Day 3 - 24 hr (7)
CL Item
Day 3 - 48 hr (8)
CL Item
Repeat Sampling (9)
Item
Cohort
integer
C0599755 (UMLS CUI [1])
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
Pharmacodynamics
C0851347 (UMLS CUI-1)
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])
Sample date/time
Item
Actual date/time
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Stop date/time of sample
Item
Stop date/time of sample
text
C0200345 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Sample Type
integer
C2347029 (UMLS CUI [1])
Code List
Sample Type
CL Item
Blood (1)
CL Item
Urine (2)
CL Item
Flow Cytometry (3)
PD Sample ID
Item
PD Sample ID
text
C1299222 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])

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