ID
42871
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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.
Länk
https://clinicaltrials.gov/ct2/show/NCT00996840
Nyckelord
Versioner (2)
- 2019-07-20 2019-07-20 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Logs and Repeats
- StudyEvent: ODM
Beskrivning
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0205341
- UMLS CUI-6
- C0220825
Beskrivning
non-serious adverse events
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
serious adverse events
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
concomitant medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
blood products
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0456388
- UMLS CUI [2,1]
- C0456388
- UMLS CUI [2,2]
- C0344211
Beskrivning
abnormal, clinically significant ECG
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
Beskrivning
repeat ECGs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beskrivning
repeat haematology or clinical chemistry samples taken
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
- UMLS CUI [2,3]
- C0205341
Beskrivning
repeat urinalysis samples
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0042014
Beskrivning
repeat Blood pharmacodynamic samples taken for external analysis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C1277698
- UMLS CUI [1,3]
- C3844314
- UMLS CUI [1,4]
- C0851347
Beskrivning
repeat urine pharmacodynamic samples taken for external analysis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0200354
- UMLS CUI [1,3]
- C3844314
- UMLS CUI [1,4]
- C0851347
Beskrivning
repeat pharmocodynamic samples taken for analysis at site
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0851347
- UMLS CUI [1,4]
- C2825164
Beskrivning
repeat pharmacokinetic samples
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
Beskrivning
repeat vital signs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0518766
Beskrivning
Liver Event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
If yes, please complete the Liver Event form(s).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0243161
- UMLS CUI [1,4]
- C2746065
- UMLS CUI [1,5]
- C0304229
Similar models
Logs and Repeats
- StudyEvent: ODM
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2985739 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C1277698 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
C0200354 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0518766 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
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