ID
37356
Description
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 continously during the study and/or at the follow-up evaluation and contains information on other medication the participant has received during the course of the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00996840
Keywords
Versions (1)
- 7/20/19 7/20/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 20, 2019
DOI
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License
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Concomitant Medications
- StudyEvent: ODM
Description
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Sequence Number
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
[hidden]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Unit Dose
Data type
text
Alias
- UMLS CUI [1]
- C0869039
Description
Concomitant Medication Units
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Frequency
Data type
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C3897500
Description
Concomitant Medication Taken Prior to Study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
If no, specify End Date and Time
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
End date and time
Data type
datetime
Alias
- UMLS CUI [1]
- C3899266
Similar models
Concomitant Medications
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])