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

Mots-clés

Versions (3)
  1. 03/08/2017 03/08/2017 -
  2. 03/08/2017 03/08/2017 -
  3. 07/09/2017 07/09/2017 -
Téléchargé le

7 septembre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

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

1 Formulaires  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Type de données

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Description

Visit Description

Type de données

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.

Type de données

boolean

Alias
UMLS CUI [1]
C0023570
Drug name
Description

(Trade Name preferred)

Type de données

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Description

Unit Dose

Type de données

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

Type de données

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

Type de données

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

Type de données

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Parkinson's

Type de données

text

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

Start Date

Type de données

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Type de données

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Type de données

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.

Type de données

boolean

Alias
UMLS CUI [1]
C3639446
Drug name
Description

(Trade Name preferred)

Type de données

text

Alias
UMLS CUI [1]
C0013227
Unit Dose
Description

Unit Dose

Type de données

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

Type de données

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

Type de données

integer

Alias
UMLS CUI [1]
C3476109
Reason for Medication
Description

Parkinson's

Type de données

text

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

Stop Date

Type de données

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
Retour au début de la page

Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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