ID

25055

Description

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.

Keywords

Versions (2)
  1. 8/25/17 8/25/17 -
  2. 9/8/17 9/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 25, 2017

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

English

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 forms  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

text

Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Description

Visit Description

Data type

text

Pregnancy information
Description

Pregnancy information

Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

text

Study conclusion
Description

Study conclusion

Date of subject completion or withdrawal
Description

Date

Data type

date

Was the subject withdrawn from the study?
Description

Withdrawal

Data type

boolean

If Yes, check the primary reason for withdrawal:
Description

reason withdrawal

Data type

text

If other reason, specify
Description

other reason withdrawal

Data type

text

Investigator comment log
Description

Investigator comment log

CRF page number if applicable
Description

CRF page number

Data type

integer

Comment
Description

Comment

Data type

text

Investigator's signature
Description

Investigator's signature

Investigator’s Signature
Description

Investigator Signature

Data type

text

Date
Description

signature date

Data type

date

Investigator’s name (print)
Description

Investigator name

Data type

text

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Similar models

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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