ID
37411
Beschreibung
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
Stichworte
Versionen (1)
- 24.07.19 24.07.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Juli 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840
Liver Events
- StudyEvent: ODM
Beschreibung
Liver Events - Lab
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0008000
Beschreibung
ALT reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
AST reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Total bilirubin reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Alkaline phosphatase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
5' nucleotidase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Gamma-glutamyltranspeptidase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Other liver chemistry result reached stopping criteria
Datentyp
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
Beschreibung
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
f Yes, answer whether the results were normal
Datentyp
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
Beschreibung
If applicable If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datentyp
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
Beschreibung
If yes, complete Liver Biopsy form.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beschreibung
If yes, record on the appropriate Concomitant Medication form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschreibung
Recent fasting or significant dietary change
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826267
Beschreibung
Investigational Product Liver
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beschreibung
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
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0013230
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C1706839
Beschreibung
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.
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0013230
Beschreibung
Pharmakokinetics Liver
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031327
- UMLS CUI-3
- C0023884
Beschreibung
An unscheduled PK blood sample must be obtained within 2 hours of last dose. If yes, answer following three items.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
if applicable
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschreibung
if applicable
Datentyp
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
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschreibung
Acute type A viral hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0276434
Beschreibung
Hepatitis B, Chronic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0524909
Beschreibung
Hepatitis C, Chronic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0524910
Beschreibung
Cytomegalovirus Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0276252
Beschreibung
Infectious Mononucleosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021345
Beschreibung
Herpes Simplex Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C1963747
Beschreibung
Alcoholic Liver Diseases
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023896
Beschreibung
Non-alcoholic Steatohepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C3241937
Beschreibung
Fatty Liver
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015695
Beschreibung
Hepatic Cirrhosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023890
Beschreibung
Hemochromatosis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018995
Beschreibung
Autoimmune Hepatitis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0241910
Beschreibung
Gall Bladder Diseases
Datentyp
integer
Alias
- UMLS CUI [1]
- C0016977
Beschreibung
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beschreibung
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Other liver disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Other Liver Disease Conditions - Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Drug Allergies
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013182
Beschreibung
Rheumatoid Arthritis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
Psoriasis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beschreibung
Thyroid Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beschreibung
Inflammatory Bowel Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
Lupus
Datentyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beschreibung
Sjogren's Syndrome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beschreibung
Vitiligo
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beschreibung
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Beschreibung
If Yes, record the average number of units of alcohol consumed per week
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
if applicable
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Ähnliche Modelle
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])