ID

25055

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 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de agosto 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

text

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descripción

Visit Description

Tipo de datos

text

Pregnancy information
Descripción

Pregnancy information

Did the subject become pregnant during the study?
Descripción

If Yes, complete Pregnancy Notification form.

Tipo de datos

text

Study conclusion
Descripción

Study conclusion

Date of subject completion or withdrawal
Descripción

Date

Tipo de datos

date

Was the subject withdrawn from the study?
Descripción

Withdrawal

Tipo de datos

boolean

If Yes, check the primary reason for withdrawal:
Descripción

reason withdrawal

Tipo de datos

text

If other reason, specify
Descripción

other reason withdrawal

Tipo de datos

text

Investigator comment log
Descripción

Investigator comment log

CRF page number if applicable
Descripción

CRF page number

Tipo de datos

integer

Comment
Descripción

Comment

Tipo de datos

text

Investigator's signature
Descripción

Investigator's signature

Investigator’s Signature
Descripción

Investigator Signature

Tipo de datos

text

Date
Descripción

signature date

Tipo de datos

date

Investigator’s name (print)
Descripción

Investigator name

Tipo de datos

text

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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
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
Item Group
Pregnancy information
Item
Did the subject become pregnant during the study?
text
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (x)
Item Group
Study conclusion
Date
Item
Date of subject completion or withdrawal
date
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
Item
If Yes, check the primary reason for withdrawal:
text
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)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Dyskinesia (28)
CL Item
Other (Z)
other reason withdrawal
Item
If other reason, specify
text
Item Group
Investigator comment log
CRF page number
Item
CRF page number if applicable
integer
Comment
Item
Comment
text
Item Group
Investigator's signature
Investigator Signature
Item
Investigator’s Signature
text
signature date
Item
Date
date
Investigator name
Item
Investigator’s name (print)
text
Volver a la parte superior de la página 

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