ID

28172

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-12-25 2017-12-25 -
Rättsinnehavare

Priv.-Doz. Dr. med. Johannes Levin

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25 december 2017

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Creative Commons BY-NC 3.0
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PROMESA NCT02008721

Engelsk

Study termination

1 Formulär  
  1. StudyEvent: ODM
    1. Study termination
End of treatment
Beskrivning

End of treatment

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

End of treatment

Datatyp

integer

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

Study medication end date

Datatyp

date

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

Decision taker end of treatment

Datatyp

integer

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

Reason for end of treatment

Datatyp

integer

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

premature treatment termination specify

Datatyp

text

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

End of study

Alias
UMLS CUI-1
C0444496
End of study
Beskrivning

End of study

Datatyp

integer

Alias
UMLS CUI [1]
C0444496
Date
Beskrivning

Date of end of study

Datatyp

date

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

Last visit

Datatyp

integer

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

Decision taker termination of study

Datatyp

integer

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

Withdrawal of informed consent

Datatyp

boolean

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

Date of withdrawal of consent

Datatyp

date

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

adverse event or serious adverse event

Datatyp

boolean

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

AE code

Datatyp

text

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

Death of patient

Datatyp

boolean

Alias
UMLS CUI [1]
C0011065
Date
Beskrivning

Date of death

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Cause of death
Beskrivning

Cause of death

Datatyp

text

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

Eligibilty criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0013893
Pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

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

Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
Significant protocol violations
Beskrivning

protocol violation

Datatyp

boolean

Alias
UMLS CUI [1]
C1709750
Significant protocol violations
Beskrivning

protocol violations

Datatyp

text

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

Lost to follow-up

Datatyp

boolean

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

Date of last contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Reason
Beskrivning

Lost to follow-up reason

Datatyp

text

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

premature termination other reason

Datatyp

text

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

Unblinding

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

Unblinding

Datatyp

boolean

Alias
UMLS CUI [1]
C3897431
Date
Beskrivning

Unblinding date

Datatyp

date

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

Unblinding Specification

Datatyp

text

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

Signature of investigator

Alias
UMLS CUI-1
C2346576
Date of Investigator Signature
Beskrivning

Investigator Signature Date

Datatyp

date

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beskrivning

I have reviewed and approved the complete CRF.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study termination

1 Formulär
  1. StudyEvent: ODM
    1. Study termination
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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