ID

25055

Beskrivning

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.

Nyckelord

Versioner (2)
  1. 2017-08-25 2017-08-25 -
  2. 2017-09-08 2017-09-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 augusti 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

Engelsk

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulär  
General information
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General information

Protocol identifier
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Protocol identifier

Datatyp

text

Subject Identifier
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Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Visit Description
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Visit Description

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text

Pregnancy information
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Pregnancy information

Did the subject become pregnant during the study?
Beskrivning

If Yes, complete Pregnancy Notification form.

Datatyp

text

Study conclusion
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Study conclusion

Date of subject completion or withdrawal
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Date

Datatyp

date

Was the subject withdrawn from the study?
Beskrivning

Withdrawal

Datatyp

boolean

If Yes, check the primary reason for withdrawal:
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reason withdrawal

Datatyp

text

If other reason, specify
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other reason withdrawal

Datatyp

text

Investigator comment log
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Investigator comment log

CRF page number if applicable
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CRF page number

Datatyp

integer

Comment
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Comment

Datatyp

text

Investigator's signature
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Investigator's signature

Investigator’s Signature
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Investigator Signature

Datatyp

text

Date
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signature date

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date

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Investigator name

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text

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Similar models

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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