ID

37324

Beschreibung

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 12 lead ECG form is to be completed at Screening, Day 2/3/4 at 0 hrs for all cohorts (Day 4 0 hrs denoted as Day 3 24 hrs), Follow-Up and for any repeat/unscheduled ECGs.

Link

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

Stichworte

Versionen (1)
  1. 17.07.19 17.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Juli 2019

DOI

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Lizenz

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

Englisch

12 Lead ECG

1 Formulare  
  1. StudyEvent: ODM
    1. 12 Lead ECG
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Beschreibung

Subject ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beschreibung

Type of Visit

Datentyp

integer

Alias
UMLS CUI [1]
C3641100
Dosing Date and Time
Beschreibung

Dosing Date and Time

Alias
UMLS CUI-1
C3897500
UMLS CUI-2
C3469597
UMLS CUI-3
C0304229
Start Dosing date/time
Beschreibung

only applicable for ECGs during medication days (Day 2, Day 3, Repeat), not for Screening and Follow-Up

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
ECG
Beschreibung

ECG

Alias
UMLS CUI-1
C1623258
Time after start dose
Beschreibung

only applicable for scheduled ECGs on Day 2 (0 hrs) and Day 3 (0 hrs, 24 hrs)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C3897500
UMLS CUI [1,4]
C3469597
UMLS CUI [1,5]
C0304229
Date and Time of ECG
Beschreibung

ECG Date / Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
Method of QTC Calculation
Beschreibung

If Machine -> record the QTC values(s) generated by the machine (QTcF/QTcB) If Manual -> record the RR interval that precedes the measured QT interval

Datentyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
QTCB Interval
Beschreibung

if applicable

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
msec
QTCF Interval
Beschreibung

if applicable

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
msec
record the RR interval that precedes the measured QT interval:
Beschreibung

if applicable

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0855331
msec
Result of the ECG
Beschreibung

if 3 = Abnormal - Clinically significant: complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

12 Lead ECG

1 Formulare
  1. StudyEvent: ODM
    1. 12 Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item
Type of Visit
integer
C3641100 (UMLS CUI [1])
Type of Visit
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Follow-up (4)
CL Item
Repeat Assessment (5)
Item Group
Dosing Date and Time
C3897500 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Start Dosing date/time
Item
Start Dosing date/time
datetime
C3897500 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Time after start dose
integer
C0439564 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C3897500 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
Time after start dose
Code List
Time after start dose
CL Item
0 hr (1)
CL Item
24 hr (2)
ECG Date / Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Item
Method of QTC Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTC Calculation
Code List
Method of QTC Calculation
CL Item
Machine (1)
CL Item
Manual (2)
QTCB Interval
Item
QTCB Interval
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
QTCF Interval
Item
QTCF Interval
float
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
manual QTc: RR interval
Item
record the RR interval that precedes the measured QT interval:
float
C0489636 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
ECG Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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