ID

25046

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: L-Dopa medication

Keywords

Versions (4)
  1. 8/18/17 8/18/17 -
  2. 8/18/17 8/18/17 -
  3. 8/25/17 8/25/17 -
  4. 9/8/17 9/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 25, 2017

DOI

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License

Creative Commons BY-NC 3.0
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L-Dopa medication GSK study Dyskinesia in Parkinson's disease NCT00363727

English

L-Dopa medication 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

L-Dopa medication changes
Description

L-Dopa medication changes

Has there been any change in dose or frequency of L-Dopa medication since the last visit?
Description

Note: Record any changes to the subject's L-Dopa medication taken since the last visit in the L-Dopa Medication section and contact GSK

Data type

boolean

L-Dopa medication
Description

L-Dopa medication

Drug name
Description

(Trade Name preferred)

Data type

text

Unit Dose
Description

Unit Dose

Data type

float

Units
Description

The following lists of abbreviations are examples which can be used to aid the completion of the appropriate items on the L-Dopa page.These are not all inclusive lists and are for guidance only, other abbreviations may be used if necessary. Abbreviation Label: TAB = Tablet, MCL = Microlitre, ML = Millilitre, L = Litre, MCG = Microgram, MG = Milligram, G = Gram

Data type

text

Frequency
Description

The following lists of abbreviations are examples which can be used to aid the completion of the appropriate items on the L-Dopa page.These are not all inclusive lists and are for guidance only, other abbreviations may be used if necessary. Abbreviation Label: OD = 1 x Daily, BID = 2 x Daily, TIO = 3x Daily, QID = 4x Daily, PRN = As required

Data type

text

Route
Description

The following lists of abbreviations are examples which can be used to aid the completion of the appropriate items on the L-Dopa page.These are not all inclusive lists and are for guidance only, other abbreviations may be used if necessary. Abbreviation Label: IM = Intramuscular, IH = Inhalation, IV = Intravenous, NS = Nasal, TP = Topical, PO = Oral, VG = Vaginal

Data type

text

Reason for Medication
Description

Reason for Medication

Data type

text

Start Date
Description

Start Date

Data type

date

Stop Date
Description

Stop Date

Data type

date

Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Parkinson's disease symptom control
Description

Parkinson's disease symptom control

Does the subject experience a reduction in Parkinson's Disease symptom control within 4 hours of the dose of L-dopa?
Description

Parkinson's Disease symptom control

Data type

boolean

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Similar models

L-Dopa medication 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
L-Dopa medication changes
change of L-Dopa medication
Item
Has there been any change in dose or frequency of L-Dopa medication since the last visit?
boolean
Item Group
L-Dopa medication
Drug name
Item
Drug name
text
Unit Dose
Item
Unit Dose
float
Units
Item
Units
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication
Item
Ongoing Medication?
boolean
Item Group
Parkinson's disease symptom control
Parkinson's Disease symptom control
Item
Does the subject experience a reduction in Parkinson's Disease symptom control within 4 hours of the dose of L-dopa?
boolean
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