ID

25057

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: PGx-Pharamacogenetic research.

Mots-clés

Versions (2)
  1. 25/08/2017 25/08/2017 -
  2. 08/09/2017 08/09/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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PGx-Pharamacogenetic research GSK study Dyskinesia in Parkinson's disease NCT00363727

Anglais

PGx-Pharamacogenetic research study Dyskinesia in Parkinson's disease NCT00363727

1 Formulaires  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Type de données

text

Subject identifier
Description

Subject identifier

Type de données

text

Consent for PGx-Pharamacogenetic research
Description

Consent for PGx-Pharamacogenetic research

Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

The question "Has informed consent been obtained for PGx-Pharmacogenetic research?" should be completed at either Visit 6, Early Withdrawal, or Follow-Up Visit. If the question is answered No, check one box for reason and do not complete the remainder of the page.

Type de données

boolean

If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Description

date consent PGx-Pharmacogenetic research

Type de données

date

If No, check one reason:
Description

reason consent unavailable

Type de données

text

If other reason, specify
Description

reason consent unavailable specification

Type de données

text

Blood sample collection (DNA)
Description

Blood sample collection (DNA)

Has a blood sample been collected for PGx-pharmacogenetic research?
Description

Blood sample collection

Type de données

boolean

If Yes, record the date sample taken
Description

Blood sample collection date

Type de données

date

Withdrawal of consent
Description

Withdrawal of consent

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

The question "Has the subject withdrawn consent for PGx-Pharmacogenetic research?" must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section below completed.

Type de données

boolean

Blood sample destruction
Description

Blood sample destruction

Has a request been made for sample destruction?
Description

Do not complete this section if a blood sample was not collected. The question "Has a request been made for sample destruction?" must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research.

Type de données

boolean

If Yes, check one reason:
Description

Blood sample destruction reason

Type de données

text

If other reason, specify
Description

Blood sample destruction reason specification

Type de données

text

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Similar models

PGx-Pharamacogenetic research 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
text
Subject identifier
Item
Subject identifier
text
Item Group
Consent for PGx-Pharamacogenetic research
Consent for PGx-pharmagogenetic research
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
date consent PGx-Pharmacogenetic research
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
Item
If No, check one reason:
text
reason consent unavailable
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (Z)
Item
If other reason, specify
text
reason consent unavailable
Code List
If other reason, specify
Item Group
Blood sample collection (DNA)
Blood sample collection
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
Blood sample collection date
Item
If Yes, record the date sample taken
date
Item Group
Withdrawal of consent
Withdrawal of consent
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
Item Group
Blood sample destruction
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
Item
If Yes, check one reason:
text
Blood sample destruction reason
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Blood sample destruction reason specification
Item
If other reason, specify
text
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