ID
37323
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 urinalysis and urine microscopy data, which are assessed at Screening, on 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). This form can also be used for any repeat/unscheduled urine laboratory tests.
Link
https://clinicaltrials.gov/ct2/show/NCT00996840
Stichworte
Versionen (2)
- 16.07.19 16.07.19 -
- 17.07.19 17.07.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Juli 2019
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
SB-681323 in ALI/ARDS risk patients - NCT00996840
Urinalysis incl. Microscopy
- StudyEvent: ODM
Beschreibung
Urinalysis Dipstick
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschreibung
if positive, answer next item ("Was sedimentary microscopy performed?")
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschreibung
If yes, provide details in the miscroscopy part below
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1261248
Beschreibung
Urinalysis Dipstick details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschreibung
Fill in all of the following items for each analysed feature at all visits.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430370
Beschreibung
Dipstick result type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
if applicable
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Beschreibung
Urinalysis Microscopy
Alias
- UMLS CUI-1
- C0430397
Beschreibung
Fill in all of the following items for each analysed feature at all visits.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430397
Beschreibung
Microscopic urinalysis result type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Beschreibung
if applicable
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2347373
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Ähnliche Modelle
Urinalysis incl. Microscopy
- StudyEvent: ODM
C0042014 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1261248 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Keine Kommentare