ID

24511

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2017-08-03 2017-08-03 -
  2. 2017-08-03 2017-08-03 -
  3. 2017-09-07 2017-09-07 -
Uppladdad den

3 augusti 2017

DOI

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

Engelsk

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

1 Formulär  
General information
Beskrivning

General information

Protocol identifier
Beskrivning

Protocol identifier

Datatyp

text

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beskrivning

Visit Description

Datatyp

text

Prior L-Dopa medication
Beskrivning

Prior L-Dopa medication

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

If Yes, record information below.

Datatyp

boolean

Drug name
Beskrivning

(Trade Name preferred)

Datatyp

text

Unit Dose
Beskrivning

Unit Dose

Datatyp

float

Units
Beskrivning

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

Datatyp

text

Frequency
Beskrivning

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

Datatyp

text

Route
Beskrivning

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

Datatyp

text

Reason for Medication
Beskrivning

Parkinson's

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Stop Date
Beskrivning

Stop Date

Datatyp

date

Ongoing Medication?
Beskrivning

Ongoing Medication

Datatyp

boolean

Prior Parkinson's medication
Beskrivning

Prior Parkinson's medication

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

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

Datatyp

boolean

Drug name
Beskrivning

(Trade Name preferred)

Datatyp

text

Unit Dose
Beskrivning

Unit Dose

Datatyp

float

Units
Beskrivning

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

Datatyp

text

Frequency
Beskrivning

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

Datatyp

text

Reason for Medication
Beskrivning

Parkinson's

Datatyp

text

Stop Date
Beskrivning

Stop Date

Datatyp

date

Ongoing Medication?
Beskrivning

Ongoing Medication

Datatyp

boolean

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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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