ID

24511

Descrizione

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: Pre-study PD medications

Keywords

versioni (3)
  1. 03/08/17 03/08/17 -
  2. 03/08/17 03/08/17 -
  3. 07/09/17 07/09/17 -
Caricato su

3 agosto 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Pre-study PD medications GSK study Dyskinesia in Parkinson's disease NCT00363727

Inglese

Pre-study PD medications GSK study Dyskinesia in Parkinson's disease NCT00363727

1 moduli  
General information
Descrizione

General information

Protocol identifier
Descrizione

Protocol identifier

Tipo di dati

text

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descrizione

Visit Description

Tipo di dati

text

Prior L-Dopa medication
Descrizione

Prior L-Dopa medication

Was any L-Dopa taken by the subject within 30 days prior to the study?
Descrizione

If Yes, record information below.

Tipo di dati

boolean

Drug name
Descrizione

(Trade Name preferred)

Tipo di dati

text

Unit Dose
Descrizione

Unit Dose

Tipo di dati

float

Units
Descrizione

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 di dati

text

Frequency
Descrizione

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 di dati

text

Route
Descrizione

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 di dati

text

Reason for Medication
Descrizione

Parkinson's

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

Stop Date
Descrizione

Stop Date

Tipo di dati

date

Ongoing Medication?
Descrizione

Ongoing Medication

Tipo di dati

boolean

Prior Parkinson's medication
Descrizione

Prior Parkinson's medication

Has the subject taken any prior Parkinson's medication (excluding L-Dopa) within 30 days prior to the study?
Descrizione

If Yes, record each medication on a separate line using Trade Names where possible.

Tipo di dati

boolean

Drug name
Descrizione

(Trade Name preferred)

Tipo di dati

text

Unit Dose
Descrizione

Unit Dose

Tipo di dati

float

Units
Descrizione

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 di dati

text

Frequency
Descrizione

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 di dati

text

Reason for Medication
Descrizione

Parkinson's

Tipo di dati

text

Stop Date
Descrizione

Stop Date

Tipo di dati

date

Ongoing Medication?
Descrizione

Ongoing Medication

Tipo di dati

boolean

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Similar models

Pre-study PD medications GSK study Dyskinesia in Parkinson's disease NCT00363727

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Prior L-Dopa medication
L-Dopa within 30 days prior to study
Item
Was any L-Dopa taken by the subject within 30 days prior to the study?
boolean
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
Prior Parkinson's medication
Parkinson's medication within 30 days prior to study
Item
Has the subject taken any prior Parkinson's medication (excluding L-Dopa) within 30 days prior to the study?
boolean
Drug name
Item
Drug name
text
Unit Dose
Item
Unit Dose
float
Units
Item
Units
text
Frequency
Item
Frequency
text
Reason for Medication
Item
Reason for Medication
text
Stop Date
Item
Stop Date
date
Ongoing Medication
Item
Ongoing Medication?
boolean
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