ID

28172

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.12.17 25.12.17 -
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Priv.-Doz. Dr. med. Johannes Levin

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25. Dezember 2017

DOI

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PROMESA NCT02008721

Englisch

Study termination

1 Formulare  
  1. StudyEvent: ODM
    1. Study termination
End of treatment
Beschreibung

End of treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0444930
End of treatment
Beschreibung

End of treatment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
Date of last intake
Beschreibung

Study medication end date

Datentyp

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Premature termination of treatment by:
Beschreibung

Decision taker end of treatment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0679006
Reason
Beschreibung

Reason for end of treatment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C3166257
Specify other reason for premature treatment termination
Beschreibung

premature treatment termination specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0871548
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1521902
End of study
Beschreibung

End of study

Alias
UMLS CUI-1
C0444496
End of study
Beschreibung

End of study

Datentyp

integer

Alias
UMLS CUI [1]
C0444496
Date
Beschreibung

Date of end of study

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Last regular visit/interview
Beschreibung

Last visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1517741
Premature termination of study by:
Beschreibung

Decision taker termination of study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Withdrawal of informed consent
Beschreibung

Withdrawal of informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1710677
Date of withdrawal of consent
Beschreibung

Date of withdrawal of consent

Datentyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
AE/SAE
Beschreibung

adverse event or serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
AE number according to AE report form
Beschreibung

AE code

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1521902
Death
Beschreibung

Death of patient

Datentyp

boolean

Alias
UMLS CUI [1]
C0011065
Date
Beschreibung

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Cause of death
Beschreibung

Cause of death

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Patient did not meet Inclusion/Exclusion Criteria.
Beschreibung

Eligibilty criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
Patient's non-compliance
Beschreibung

Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Significant protocol violations
Beschreibung

protocol violation

Datentyp

boolean

Alias
UMLS CUI [1]
C1709750
Significant protocol violations
Beschreibung

protocol violations

Datentyp

text

Alias
UMLS CUI [1]
C1709750
Lost to follow-up
Beschreibung

Lost to follow-up

Datentyp

boolean

Alias
UMLS CUI [1]
C1302313
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Reason
Beschreibung

Lost to follow-up reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1302313
UMLS CUI [1,2]
C0566251
other (please specify)
Beschreibung

premature termination other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2718058
UMLS CUI [1,2]
C0566251
Unblinding
Beschreibung

Unblinding

Alias
UMLS CUI-1
C3897431
Unblinding (independent from regular or premature study termination)
Beschreibung

Unblinding

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date
Beschreibung

Unblinding date

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Specification
Beschreibung

Unblinding Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2348235
Signature of investigator
Beschreibung

Signature of investigator

Alias
UMLS CUI-1
C2346576
Date of Investigator Signature
Beschreibung

Investigator Signature Date

Datentyp

date

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

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschreibung

I have reviewed and approved the complete CRF.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Study termination

1 Formulare
  1. StudyEvent: ODM
    1. Study termination
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
End of treatment
C0087111 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Item
End of treatment
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
End of treatment
Code List
End of treatment
CL Item
regular termination of treatment (V6) (1)
CL Item
premature termination of treatment (2)
Study medication end date
Item
Date of last intake
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Premature termination of treatment by:
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Decision taker end of treatment
Code List
Premature termination of treatment by:
CL Item
Patient (1)
CL Item
Investigator (2)
CL Item
LKP (3)
CL Item
SDP (4)
Item
Reason
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C3166257 (UMLS CUI [1,3])
Reason for end of treatment
Code List
Reason
CL Item
AE/SAE (1)
CL Item
Compliance (2)
CL Item
Hepatotoxicity (3)
CL Item
other (specify) (4)
premature treatment termination specify
Item
Specify other reason for premature treatment termination
text
C0871548 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
End of study
C0444496 (UMLS CUI-1)
Item
End of study
integer
C0444496 (UMLS CUI [1])
End of study
Code List
End of study
CL Item
regular termination after last visit (Visit 7) (1)
CL Item
premature termination (2)
Date of end of study
Item
Date
date
C2983670 (UMLS CUI [1])
Item
Last regular visit/interview
integer
C0545082 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Last visit
Code List
Last regular visit/interview
CL Item
V1 (1)
CL Item
V2 (2)
CL Item
V3 (3)
CL Item
V4 (4)
CL Item
T1 (5)
CL Item
V5  (6)
CL Item
T2 (7)
CL Item
V6 (8)
Item
Premature termination of study by:
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taker termination of study
Code List
Premature termination of study by:
CL Item
Patient (1)
CL Item
Investigator (2)
CL Item
PI/LKP (3)
CL Item
Sponsor (4)
Withdrawal of informed consent
Item
Withdrawal of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Date of withdrawal of consent
Item
Date of withdrawal of consent
date
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
adverse event or serious adverse event
Item
AE/SAE
boolean
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
AE code
Item
AE number according to AE report form
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Death of patient
Item
Death
boolean
C0011065 (UMLS CUI [1])
Date of death
Item
Date
date
C1148348 (UMLS CUI [1])
Cause of death
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Eligibilty criteria
Item
Patient did not meet Inclusion/Exclusion Criteria.
boolean
C0013893 (UMLS CUI [1])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Compliance
Item
Patient's non-compliance
boolean
C1321605 (UMLS CUI [1])
protocol violation
Item
Significant protocol violations
boolean
C1709750 (UMLS CUI [1])
protocol violations
Item
Significant protocol violations
text
C1709750 (UMLS CUI [1])
Lost to follow-up
Item
Lost to follow-up
boolean
C1302313 (UMLS CUI [1])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Lost to follow-up reason
Item
Reason
text
C1302313 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
premature termination other reason
Item
other (please specify)
text
C2718058 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Unblinding
C3897431 (UMLS CUI-1)
Unblinding
Item
Unblinding (independent from regular or premature study termination)
boolean
C3897431 (UMLS CUI [1])
Unblinding date
Item
Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Unblinding Specification
Item
Specification
text
C3897431 (UMLS CUI [1,1])
C2348235 (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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