ID

25055

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 25-08-17 25-08-17 -
  2. 08-09-17 08-09-17 -
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GlaxoSmithKline

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25 augustus 2017

DOI

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

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Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren  
General information
Beschrijving

General information

Protocol identifier
Beschrijving

Protocol identifier

Datatype

text

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beschrijving

Visit Description

Datatype

text

Pregnancy information
Beschrijving

Pregnancy information

Did the subject become pregnant during the study?
Beschrijving

If Yes, complete Pregnancy Notification form.

Datatype

text

Study conclusion
Beschrijving

Study conclusion

Date of subject completion or withdrawal
Beschrijving

Date

Datatype

date

Was the subject withdrawn from the study?
Beschrijving

Withdrawal

Datatype

boolean

If Yes, check the primary reason for withdrawal:
Beschrijving

reason withdrawal

Datatype

text

If other reason, specify
Beschrijving

other reason withdrawal

Datatype

text

Investigator comment log
Beschrijving

Investigator comment log

CRF page number if applicable
Beschrijving

CRF page number

Datatype

integer

Comment
Beschrijving

Comment

Datatype

text

Investigator's signature
Beschrijving

Investigator's signature

Investigator’s Signature
Beschrijving

Investigator Signature

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text

Date
Beschrijving

signature date

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date

Investigator’s name (print)
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text

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Similar models

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Terug naar het begin van de pagina 

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