ID
37370
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 the participant's vital signs including ventilator settings, which are assessed at Screening, on Day 1 at 4 hrs (cohorts 1 and 3 only), Day 2 at 0 hrs, Day 3 at 0 hrs, Day 3 at 24 hrs (i.e. Day 4 at 0 hrs), and Follow-Up (for all cohorts, except for Day 1 at 4 hrs). This form can also be used for any repeat/unscheduled assessment of vital signs.
Link
https://clinicaltrials.gov/ct2/show/NCT00996840
Stichworte
Versionen (1)
- 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
Vitals Signs
- StudyEvent: ODM
Beschreibung
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Date/time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C1264639
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
calculated from height and weight
Datentyp
float
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
if done
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
if done
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
if done
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Oxygen Administration
Alias
- UMLS CUI-1
- C0184633
Beschreibung
If ventilator, give details in following questions
Datentyp
text
Alias
- UMLS CUI [1]
- C0809836
Beschreibung
if applicable if 6 = Other, please specify
Datentyp
integer
Alias
- UMLS CUI [1]
- C0808387
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0808387
- UMLS CUI [1,3]
- C2348235
Beschreibung
If yes, give value in next question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040210
- UMLS CUI [1,2]
- C1706839
Beschreibung
if applicable
Datentyp
float
Maßeinheiten
- mL
Alias
- UMLS CUI [1]
- C0040210
Beschreibung
If yes, give value in next question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0428679
- UMLS CUI [1,2]
- C1148554
- UMLS CUI [1,3]
- C0332149
Beschreibung
if determinable
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0428679
Beschreibung
If yes, give value in next question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0807495
- UMLS CUI [1,2]
- C1148554
- UMLS CUI [1,3]
- C0332149
Beschreibung
if determinable
Datentyp
integer
Maßeinheiten
- cm H2O
Alias
- UMLS CUI [1]
- C0032740
Beschreibung
If yes, give value in next question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232021C1148554
- UMLS CUI [1,2]
- C0332149
Beschreibung
if determinable
Datentyp
integer
Maßeinheiten
- cm H2O
Alias
- UMLS CUI [1]
- C0232021
Beschreibung
If yes, give value in next question.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0445176
- UMLS CUI [1,2]
- C1148554
- UMLS CUI [1,3]
- C0332149
Beschreibung
if determinable
Datentyp
integer
Maßeinheiten
- cm H2O
Alias
- UMLS CUI [1]
- C0445176
Beschreibung
in Percent or Litre/min (see next item)
Datentyp
float
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C4534306
Beschreibung
Oxygen Requirement units
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C4534306
- UMLS CUI [2]
- C1519795
Beschreibung
Pulse Oximeter
Alias
- UMLS CUI-1
- C0034108
Beschreibung
ABG
Alias
- UMLS CUI-1
- C2598151
Ähnliche Modelle
Vitals Signs
- StudyEvent: ODM
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0808387 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1706839 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C1148554 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C4534306 (UMLS CUI [1,2])
C4534306 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2])
C0884358 (UMLS CUI [1,2])