ID
37411
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 if an Adverse Liver Event occurs, and can be used for investigations such as repeat pharmacokinetic samples or specific medical history relating to this Liver Event, however there are seperate forms for Liver Imaging and Liver Biopsy (if performed).
Link
https://clinicaltrials.gov/ct2/show/NCT00996840
Trefwoorden
Versies (1)
- 24-07-19 24-07-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 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
Liver Events
- StudyEvent: ODM
Beschrijving
Liver Events - Lab
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0008000
Beschrijving
ALT reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
AST reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Total bilirubin reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Alkaline phosphatase reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
5' nucleotidase reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Gamma-glutamyltranspeptidase reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Other liver chemistry result reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0008000
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Beschrijving
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If yes, ensure Pregnancy Notification Form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
f Yes, answer whether the results were normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C0412534
- UMLS CUI [4]
- C0412620
- UMLS CUI [5]
- C0412693
- UMLS CUI [6]
- C0008310
Beschrijving
If applicable If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0456984
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C0023884
Beschrijving
If yes, complete Liver Biopsy form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beschrijving
If yes, record on the appropriate Concomitant Medication form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschrijving
Recent fasting or significant dietary change
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826267
Beschrijving
Investigational Product Liver
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. If applicale
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
Beschrijving
Pharmakokinetics Liver
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
- UMLS CUI-3
- C0023884
Beschrijving
An unscheduled PK blood sample must be obtained within 2 hours of last dose. If yes, answer following three items.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
if applicable
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschrijving
if applicable
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0945778
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Beschrijving
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschrijving
Acute type A viral hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0276434
Beschrijving
Hepatitis B, Chronic
Datatype
integer
Alias
- UMLS CUI [1]
- C0524909
Beschrijving
Hepatitis C, Chronic
Datatype
integer
Alias
- UMLS CUI [1]
- C0524910
Beschrijving
Cytomegalovirus Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0276252
Beschrijving
Infectious Mononucleosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0021345
Beschrijving
Herpes Simplex Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C1963747
Beschrijving
Alcoholic Liver Diseases
Datatype
integer
Alias
- UMLS CUI [1]
- C0023896
Beschrijving
Non-alcoholic Steatohepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C3241937
Beschrijving
Fatty Liver
Datatype
integer
Alias
- UMLS CUI [1]
- C0015695
Beschrijving
Hepatic Cirrhosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0023890
Beschrijving
Hemochromatosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0018995
Beschrijving
Autoimmune Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0241910
Beschrijving
Gall Bladder Diseases
Datatype
integer
Alias
- UMLS CUI [1]
- C0016977
Beschrijving
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beschrijving
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Other liver disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Other Liver Disease Conditions - Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschrijving
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Drug Allergies
Datatype
integer
Alias
- UMLS CUI [1]
- C0013182
Beschrijving
Rheumatoid Arthritis
Datatype
integer
Alias
- UMLS CUI [1]
- C0003873
Beschrijving
Psoriasis
Datatype
integer
Alias
- UMLS CUI [1]
- C0033860
Beschrijving
Thyroid Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0040128
Beschrijving
Inflammatory Bowel Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Lupus
Datatype
integer
Alias
- UMLS CUI [1]
- C0409974
Beschrijving
Sjogren's Syndrome
Datatype
integer
Alias
- UMLS CUI [1]
- C1527336
Beschrijving
Vitiligo
Datatype
integer
Alias
- UMLS CUI [1]
- C0042900
Beschrijving
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Beschrijving
If Yes, record the average number of units of alcohol consumed per week
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
if applicable
Datatype
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Similar models
Liver Events
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C1272695 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0023884 (UMLS CUI-2)
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0031327 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0041755 (UMLS CUI-2)
C0041755 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])