ID

25633

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: Pre-study PD medications

Keywords

Versions (3)
  1. 8/3/17 8/3/17 -
  2. 8/3/17 8/3/17 -
  3. 9/7/17 9/7/17 -
Uploaded on

September 7, 2017

DOI

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License

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

English

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

1 forms  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Description

Visit Description

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Prior L-Dopa medication
Description

Prior L-Dopa medication

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

If Yes, record information below.

Data type

boolean

Alias
UMLS CUI [1]
C0023570
Drug name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C0869039
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

Alias
UMLS CUI [1]
C1519795
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

integer

Alias
UMLS CUI [1]
C3476109
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

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Parkinson's

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Prior Parkinson's medication
Description

Prior Parkinson's medication

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

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

Data type

boolean

Alias
UMLS CUI [1]
C3639446
Drug name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C0869039
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

integer

Alias
UMLS CUI [1]
C1519795
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

integer

Alias
UMLS CUI [1]
C3476109
Reason for Medication
Description

Parkinson's

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Pre-study PD medications 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
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
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
C0023570 (UMLS CUI [1])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Route
Item
Route
integer
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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
C3639446 (UMLS CUI [1])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Units
Item
Units
integer
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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