ID
37356
Descripción
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
Palabras clave
Versiones (1)
- 20/7/19 20/7/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de julio de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Concomitant Medications
- StudyEvent: ODM
Descripción
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Descripción
Sequence Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348184
Descripción
Trade Name preferred
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826819
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Descripción
[hidden]
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Unit Dose
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0869039
Descripción
Concomitant Medication Units
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant Medication Frequency
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Descripción
Reason for Medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Descripción
Start Date and Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C3897500
Descripción
Concomitant Medication Taken Prior to Study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826667
Descripción
If no, specify End Date and Time
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826666
Descripción
End date and time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C3899266
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Concomitant Medications
- StudyEvent: ODM
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C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
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