ID

28167

Description

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

Keywords

Versions (1)
  1. 12/22/17 12/22/17 -
Copyright Holder

Priv.-Doz. Dr. med. Johannes Levin

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December 22, 2017

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Creative Commons BY-NC 3.0
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PROMESA NCT02008721

English

Telephone visit 2 (T2)

1 forms  
  1. StudyEvent: ODM
    1. Telephone visit 2 (T2)
Date of Telephone contact
Description

Date of Telephone contact

Alias
UMLS CUI-1
C0302186
UMLS CUI-2
C0011008
Date of telephone contact
Description

Date of telephone contact

Data type

date

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0011008
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Adverse event occurred?
Description

If yes, please fill in AE report form.

Data type

boolean

Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Are there any changes in the concomitant medication?
Description

If Yes, please fill in Concomitant Medication Record.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Study medication
Description

Study medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
Did any study-drug side effects occur?
Description

If yes, please fill out AE form!

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0041755
Did the patient regularly take the study-drug?
Description

regular intake of study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0205272
If no, please explain:
Description

Study medication intake

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0205272
Regimen
Description

e.g. 1-0-0

Data type

text

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
Total dose (mg/d)
Description

Total dose

Data type

integer

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C1521826
Laboratory test
Description

Laboratory test

Alias
UMLS CUI-1
C0022885
Date
Description

Please fill in the raised values and assess whether they´re normal or not. If abnormal, evaluate if it is clinically significant or not. If the value is abnormal and clinically significant, please document as concomitant disease under medical history.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Laboratory test performed?
Description

laboratory procedures

Data type

text

Alias
UMLS CUI [1]
C0022885
Laboratory test
Description

Laboratory test

Alias
UMLS CUI-1
C0022885
Type of laboratory procedure
Description

Type of laboratory procedure

Data type

integer

Alias
UMLS CUI [1]
C0022885
Value
Description

Laboratory procedure value

Data type

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0587081
Normal
Description

Laboratory result normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0459422
Clinical significant
Description

Laboratory finding significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Clinically not significant
Description

Laboratory finding not significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2985739
Not done
Description

Laboratory test not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
Signature of investigator
Description

Signature of investigator

Alias
UMLS CUI-1
C2346576
Date of Investigator Signature
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

I confirm the correctness of the data documented above.

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Telephone visit 2 (T2)

1 forms
  1. StudyEvent: ODM
    1. Telephone visit 2 (T2)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Telephone contact
C0302186 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Date of telephone contact
Item
Date of telephone contact
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Adverse event
C0877248 (UMLS CUI-1)
adverse event
Item
Adverse event occurred?
boolean
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Are there any changes in the concomitant medication?
boolean
C2347852 (UMLS CUI [1])
Item Group
Study medication
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
side effects study drug
Item
Did any study-drug side effects occur?
boolean
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
regular intake of study medication
Item
Did the patient regularly take the study-drug?
boolean
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study medication intake
Item
If no, please explain:
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study drug regimen
Item
Regimen
text
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Total dose (mg/d)
integer
C2986497 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Total dose
Code List
Total dose (mg/d)
CL Item
800 (1)
CL Item
1200 (2)
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item
Laboratory test performed?
text
C0022885 (UMLS CUI [1])
laboratory procedures
Code List
Laboratory test performed?
CL Item
done (1)
CL Item
not done (2)
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Item
Type of laboratory procedure
integer
C0022885 (UMLS CUI [1])
Type of laboratory procedure
Code List
Type of laboratory procedure
CL Item
GOT (AST) U/L (1)
CL Item
GPT (ALT) U/L (2)
CL Item
Bilirubin mg/dL (3)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Item Group
Signature of investigator
C2346576 (UMLS CUI-1)
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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