ID
37356
Beschrijving
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
Trefwoorden
Versies (1)
- 20-07-19 20-07-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 juli 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Concomitant Medications
- StudyEvent: ODM
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Sequence Number
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Unit Dose
Datatype
text
Alias
- UMLS CUI [1]
- C0869039
Beschrijving
Concomitant Medication Units
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C3897500
Beschrijving
Concomitant Medication Taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
If no, specify End Date and Time
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
End date and time
Datatype
datetime
Alias
- UMLS CUI [1]
- C3899266
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Concomitant Medications
- StudyEvent: ODM
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C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
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