ID
37373
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 with data regarding pharmacokinetic samples, taken repeatedly on Day 1, 2 and 3 (times vary depending on cohort), and can also be used for repeat analyses.
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
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Licentie
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Pharmacokinetics Blood
- StudyEvent: ODM
Beschrijving
Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beschrijving
[read-only]
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Beschrijving
Times of sampling varies depending on Cohort: For Cohorts 1/3: Cohorts 1/3 on Day 1: 0 hr, 4 hr, 4.25 hr, 5 hr, 8 hr, 12 hr. Cohorts 1/3 on Day 2: 0 hr. Cohorts 1/3 on Day 3: 0 hr, 24 hr. For Cohorts 2/4: Cohorts 2/4 on Day 1: 0 hr. Cohorts 2/4 on Day 2: 0 hr. Cohorts 2/4 on Day 3: 0 hr, 24 hr, 24 hr 10 min, 24 hr 45 min, 27 hr, 34 hr, 40 hr, 48 hr. In total, there are 9 samples collected for Cohorts 1 and 3, and 10 samples for Cohorts 2 and 4. This item is not required for Repeat Pharmacokinetics
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0439568
- UMLS CUI [1,3]
- C0304229
Beschrijving
Sample date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C0031328
Beschrijving
for Repeat Pharmacokinetics only
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0201734
Similar models
Pharmacokinetics Blood
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])