ID

37674

Beschrijving

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 results relating to the coagulation system and lung epithelial cell injury, taken repeatedly on Day 1 and 3, and can also be used for repeat analyses.

Link

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

Trefwoorden

Versies (2)
  1. 13-08-19 13-08-19 -
  2. 15-08-19 15-08-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 augustus 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840

Engels

Pharmacodynamics Results

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beschrijving

Results should be filled in for all of the following scheduled samples (time relative to the start of dose). This is identical for all cohorts. Select option 8 for repeat/unscheduled assessments.

Datatype

integer

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

Cohort

Datatype

integer

Alias
UMLS CUI [1]
C0599755
Pharmacodynamics Results
Beschrijving

Pharmacodynamics Results

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C1254595
Start Dosing date/time
Beschrijving

[read-only]

Datatype

datetime

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

Sample date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0031328
INR Result Type
Beschrijving

INR Result Type

Datatype

integer

Alias
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
INR Numeric Result
Beschrijving

if applicable

Datatype

float

Alias
UMLS CUI [1,1]
C2347373
UMLS CUI [1,2]
C0525032
INR text result
Beschrijving

if applicable

Datatype

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C0525032
PT Result Type
Beschrijving

PT Result Type

Datatype

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0491338
PT Numeric Result
Beschrijving

if applicable

Datatype

float

Alias
UMLS CUI [1,1]
C2347373
UMLS CUI [1,2]
C0491338
PT text result
Beschrijving

if applicable

Datatype

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C0491338
PTT Result Type
Beschrijving

PTT Result Type

Datatype

integer

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
PTT Numeric Result
Beschrijving

if applicable

Datatype

float

Alias
UMLS CUI [1,1]
C2347373
UMLS CUI [1,2]
C0030605
PTT text result
Beschrijving

if applicable

Datatype

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C0030605
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Similar models

Pharmacodynamics Results

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Type of Visit
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 3 - 0 hr (5)
CL Item
Day 3 - 24 hr (6)
CL Item
Day 3 - 48 hr (7)
CL Item
Repeat Sampling (8)
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
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 Results
C0851347 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
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])
Item
INR Result Type
integer
C0525032 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
INR Result Type
Code List
INR Result Type
CL Item
Numeric result (98)
CL Item
Text result (99)
INR Numeric Result
Item
INR Numeric Result
float
C2347373 (UMLS CUI [1,1])
C0525032 (UMLS CUI [1,2])
INR text result
Item
INR text result
text
C1274040 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C0525032 (UMLS CUI [1,3])
Item
PT Result Type
integer
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0491338 (UMLS CUI [1,3])
INR Result Type
Code List
PT Result Type
CL Item
Numeric result (98)
CL Item
Text result (99)
PT Numeric Result
Item
PT Numeric Result
float
C2347373 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
PT text result
Item
PT text result
text
C1274040 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C0491338 (UMLS CUI [1,3])
Item
PTT Result Type
integer
C0030605 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
INR Result Type
Code List
PTT Result Type
CL Item
Numeric result (98)
CL Item
Text result (99)
PTT Numeric Result
Item
PTT Numeric Result
float
C2347373 (UMLS CUI [1,1])
C0030605 (UMLS CUI [1,2])
PTT text result
Item
PTT text result
text
C1274040 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C0030605 (UMLS CUI [1,3])
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