ID

25665

Beschreibung

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

Stichworte

Versionen (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 -
Hochgeladen am

8. September 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
General information
Beschreibung

General information

Protocol identifier
Beschreibung

Protocol identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beschreibung

Visit Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
L-Dopa medication changes
Beschreibung

L-Dopa medication changes

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
L-Dopa medication
Beschreibung

L-Dopa medication

Drug name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Beschreibung

Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

integer

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

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

Ongoing Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Parkinson's disease symptom control
Beschreibung

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?
Beschreibung

Parkinson's Disease symptom control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274136
UMLS CUI [1,2]
C0030567
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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
C0023570 (UMLS CUI [1])
Item Group
L-Dopa medication
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
integer
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
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
C1274136 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
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