ID

24676

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: Dyskinesias.

Keywords

Versions (2)
  1. 8/12/17 8/12/17 -
  2. 9/8/17 9/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 12, 2017

DOI

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License

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

English

Dyskinesias 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

Visit Date
Description

Visit Date

Data type

date

Visit Description
Description

Visit Description

Data type

text

Dyskinesia
Description

Dyskinesia

Is dyskinesia present?
Description

Complete the Dyskinesia panel at each visit. Determine, using your own clinical judgement whether the subject has dyskinesia. Do not confuse morning dystonia for dyskinesia. If dyskinesia is Yes, make sure all information is transferred to the Early Withdrawal Visit and that the Study Conclusion page is completed correctly.

Data type

boolean

If yes, check only one box below and complete Study Conclusion page.
Description

If you have determined that the subject has dyskinesia, Check Yes for dyskinesia and complete the bottom part of the dyskinesia panel to explain how you reach your conclusion. That is, (1) you observed the subject in clinic with dyskinesia, or (2) the verbal history that the subject related to you at this visit clearly and unequivocally provided an account of dyskinesia even though it was not present during the visit. Where there is doubt as to whether the verbal description provided by the subject was not clear enough to be considered dyskinesia. then make a note to this effect in your source documents and check No on the dyskinesia panel. If at the next consecutive visit the subject provides you with a similar account, you may then note this subject as dyskinetic and check the third check box, History suspicious and noted at 2 consecutive visits.

Data type

integer

Date of Onset
Description

Make sure the date of onset of dyskinesia is between the last visit date and this visit date.

Data type

date

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Similar models

Dyskinesias 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
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description
text
Item Group
Dyskinesia
Presence of dyskinesia
Item
Is dyskinesia present?
boolean
Item
If yes, check only one box below and complete Study Conclusion page.
integer
Dyskinesia history
Code List
If yes, check only one box below and complete Study Conclusion page.
CL Item
Dyskinesia present at clinic visit and observed by Pl (1)
CL Item
Dyskinesia history is unequivocal (2)
CL Item
History suspicious and reported at 2 consecutive visits (3)
Onset of dyskinesia
Item
Date of Onset
date
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