ID

25667

Descripción

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Study conclusion.

Palabras clave

Versiones (2)
  1. 25/8/17 25/8/17 -
  2. 8/9/17 8/9/17 -
Subido en

8 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

Inglés

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 formularios  
General information
Descripción

General information

Protocol identifier
Descripción

Protocol identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descripción

Visit Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Pregnancy information
Descripción

Pregnancy information

Did the subject become pregnant during the study?
Descripción

If Yes, complete Pregnancy Notification form.

Tipo de datos

text

Alias
UMLS CUI [1]
C0032961
Study conclusion
Descripción

Study conclusion

Date of subject completion or withdrawal
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Was the subject withdrawn from the study?
Descripción

Withdrawal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
If Yes, check the primary reason for withdrawal:
Descripción

reason withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If other reason, specify
Descripción

other reason withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C3840932
Investigator comment log
Descripción

Investigator comment log

CRF page number if applicable
Descripción

CRF page number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C1515022
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Descripción

Investigator's signature

Investigator’s Signature
Descripción

Investigator Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

signature date

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Investigator’s name (print)
Descripción

Investigator name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Pregnancy information
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
C0549206 (UMLS CUI-1)
(Comment:en)
CL Item
No (N)
C0232973 (UMLS CUI-1)
(Comment:en)
CL Item
Not Applicable (not of childbearing potential or male) (x)
C1272460 (UMLS CUI-1)
(Comment:en)
Item Group
Study conclusion
Date
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1])
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If Yes, check the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (2)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Protocol violation (3)
C1709750 (UMLS CUI-1)
(Comment:en)
CL Item
Subject decided to withdraw from the study (4)
C2348571 (UMLS CUI-1)
(Comment:en)
CL Item
Lack of efficacy (5)
C0235828 (UMLS CUI-1)
(Comment:en)
CL Item
Sponsor terminated study (6)
C1710224 (UMLS CUI-1)
(Comment:en)
CL Item
Dyskinesia (28)
C0013384 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Z)
C0205394 (UMLS CUI-1)
(Comment:en)
other reason withdrawal
Item
If other reason, specify
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Investigator comment log
CRF page number
Item
CRF page number if applicable
integer
C0237753 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1515022 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
signature date
Item
Date
date
C0807937 (UMLS CUI [1])
Investigator name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
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