ID

25633

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: Pre-study PD medications

Palavras-chave

Versões (3)
  1. 03/08/2017 03/08/2017 -
  2. 03/08/2017 03/08/2017 -
  3. 07/09/2017 07/09/2017 -
Transferido a

7 de setembro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

Inglês

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

1 Formulários  
General information
Descrição

General information

Protocol identifier
Descrição

Protocol identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descrição

Visit Description

Tipo de dados

text

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

Prior L-Dopa medication

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

If Yes, record information below.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023570
Drug name
Descrição

(Trade Name preferred)

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Descrição

Unit Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C0869039
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

Alias
UMLS CUI [1]
C1519795
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

integer

Alias
UMLS CUI [1]
C3476109
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

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Descrição

Parkinson's

Tipo de dados

text

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

Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrição

Stop Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Descrição

Ongoing Medication

Tipo de dados

boolean

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

Prior Parkinson's medication

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

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3639446
Drug name
Descrição

(Trade Name preferred)

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Descrição

Unit Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C0869039
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

integer

Alias
UMLS CUI [1]
C1519795
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

integer

Alias
UMLS CUI [1]
C3476109
Reason for Medication
Descrição

Parkinson's

Tipo de dados

text

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

Stop Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Descrição

Ongoing Medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666
Voltar ao início da página

Similar models

Pre-study PD medications 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
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial