ID

37354

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 form contains details on the administration of the investigational product and is to be filled in at Day 1, 2 and 3. Additionally, this form also contains Randomisation information and the assignment of the participant to one of the four cohorts for/prior to the first medication administration.

Link

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

Stichworte

Versionen (2)
  1. 16.07.19 16.07.19 -
  2. 20.07.19 20.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. 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

Investigational Product - IV Dosing, Randomisation, Cohort Assignment

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject ID
Beschreibung

Subject ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

please fill in the form for each of the three study days

Datentyp

integer

Alias
UMLS CUI [1]
C1320303
Which Cohort is the subject enrolled in?
Beschreibung

Please ensure the Cohort selected is correct before submitting. Medication is infused over 4 or 24 hours depending on the cohort.

Datentyp

text

Alias
UMLS CUI [1]
C0599755
Date/Time of Cohort Assignment
Beschreibung

Date/Time of Cohort Assignment

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C1516050
UMLS CUI [1,3]
C1264639
First Administration
Beschreibung

First Administration

Alias
UMLS CUI-1
C3469597
Dosage Duration (per Protocol)
Beschreibung

Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24hrs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Start Date and Time
Beschreibung

Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Beschreibung

Stop Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C3899266
Volume administered (mL)
Beschreibung

Volume administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C2349139
mL
Administration post interruption
Beschreibung

Administration post interruption

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0687676
UMLS CUI-3
C1512900
Dosage Duration (per Protocol)
Beschreibung

Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24 hrs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Start Date and Time
Beschreibung

Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Beschreibung

Stop Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C3899266
Volume administered (mL)
Beschreibung

Volume administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1]
C2349139
mL
Investigational Product Container Number
Beschreibung

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational Product Container Number
Beschreibung

Record the identifying number from the investigational product container dispensed at this visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Treatment Confirmation
Beschreibung

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

If no, record reasons

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
Reason incorrect treatment
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3827420
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschreibung

If yes, provide Randomisation Number and Date/time of randomisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Randomisation Number
Beschreibung

if applicable

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date/time of randomisation
Beschreibung

if applicable

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1264639
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Ähnliche Modelle

Investigational Product - IV Dosing, Randomisation, Cohort Assignment

1 Formulare
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
Date of Visit
integer
C1320303 (UMLS CUI [1])
Date of Visit
Code List
Date of Visit
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Item
Which Cohort is the subject enrolled in?
text
C0599755 (UMLS CUI [1])
Cohort
Code List
Which Cohort is the subject enrolled in?
CL Item
Cohort 1 (3mg/Placebo IV / 4hrs) (C1)
CL Item
Cohort 2 (7.5mg/Placebo IV / 24hrs) (C2)
CL Item
Cohort 3 (7.5mg/Placebo IV / 4hrs) (C3)
CL Item
Cohort 4 (10mg/Placebo IV / 24hrs) (C4)
Date/Time of Cohort Assignment
Item
Date/Time of Cohort Assignment
datetime
C0599755 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
First Administration
C3469597 (UMLS CUI-1)
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dosage Duration
Code List
Dosage Duration (per Protocol)
CL Item
0-4 hrs (1)
CL Item
0-24 hrs (2)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Item Group
Administration post interruption
C3469597 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dosage Duration
Code List
Dosage Duration (per Protocol)
CL Item
0-4 hrs (1)
CL Item
0-24 hrs (2)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Correct treatment received
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Reason incorrect treatment
Item
Reason incorrect treatment
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomisation Date/Time
Item
Date/time of randomisation
datetime
C0034656 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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