ID

25046

Descrição

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

Palavras-chave

Versões (4)
  1. 18/08/2017 18/08/2017 -
  2. 18/08/2017 18/08/2017 -
  3. 25/08/2017 25/08/2017 -
  4. 08/09/2017 08/09/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de agosto de 2017

DOI

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Licença

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

Inglês

L-Dopa medication GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulários  
General information
Descrição

General information

Protocol identifier
Descrição

Protocol identifier

Tipo de dados

text

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descrição

Visit Description

Tipo de dados

text

L-Dopa medication changes
Descrição

L-Dopa medication changes

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

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

Tipo de dados

boolean

L-Dopa medication
Descrição

L-Dopa medication

Drug name
Descrição

(Trade Name preferred)

Tipo de dados

text

Unit Dose
Descrição

Unit Dose

Tipo de dados

float

Units
Descrição

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

Tipo de dados

text

Frequency
Descrição

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

Tipo de dados

text

Route
Descrição

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

Tipo de dados

text

Reason for Medication
Descrição

Reason for Medication

Tipo de dados

text

Start Date
Descrição

Start Date

Tipo de dados

date

Stop Date
Descrição

Stop Date

Tipo de dados

date

Ongoing Medication?
Descrição

Ongoing Medication

Tipo de dados

boolean

Parkinson's disease symptom control
Descrição

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?
Descrição

Parkinson's Disease symptom control

Tipo de dados

boolean

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Similar models

L-Dopa medication GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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