ID
37354
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00996840
Nyckelord
Versioner (2)
- 2019-07-16 2019-07-16 -
- 2019-07-20 2019-07-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 juli 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
SB-681323 in ALI/ARDS risk patients - NCT00996840
Investigational Product - IV Dosing, Randomisation, Cohort Assignment
Beskrivning
First Administration
Alias
- UMLS CUI-1
- C3469597
Beskrivning
Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24hrs
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beskrivning
Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3897500
Beskrivning
Stop Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3899266
Beskrivning
Volume administered
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1]
- C2349139
Beskrivning
Administration post interruption
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0687676
- UMLS CUI-3
- C1512900
Beskrivning
Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24 hrs
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beskrivning
Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3897500
Beskrivning
Stop Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3899266
Beskrivning
Volume administered
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1]
- C2349139
Beskrivning
Investigational Product Container Number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
- UMLS CUI-3
- C0600091
Beskrivning
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Beskrivning
If no, record reasons
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C3827420
Beskrivning
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beskrivning
If yes, provide Randomisation Number and Date/time of randomisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0332149
Beskrivning
if applicable
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
if applicable
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1264639
Similar models
Investigational Product - IV Dosing, Randomisation, Cohort Assignment
C1516050 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0687676 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C2349182 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])