ID

25046

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: L-Dopa medication

Trefwoorden

Versies (4)
  1. 18-08-17 18-08-17 -
  2. 18-08-17 18-08-17 -
  3. 25-08-17 25-08-17 -
  4. 08-09-17 08-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 augustus 2017

DOI

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Licentie

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

Engels

L-Dopa medication 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

L-Dopa medication changes
Beschrijving

L-Dopa medication changes

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

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

Datatype

boolean

L-Dopa medication
Beschrijving

L-Dopa medication

Drug name
Beschrijving

(Trade Name preferred)

Datatype

text

Unit Dose
Beschrijving

Unit Dose

Datatype

float

Units
Beschrijving

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

Datatype

text

Frequency
Beschrijving

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

Datatype

text

Route
Beschrijving

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

Datatype

text

Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Stop Date
Beschrijving

Stop Date

Datatype

date

Ongoing Medication?
Beschrijving

Ongoing Medication

Datatype

boolean

Parkinson's disease symptom control
Beschrijving

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?
Beschrijving

Parkinson's Disease symptom control

Datatype

boolean

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Similar models

L-Dopa medication 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
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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