ID

25055

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: Study conclusion.

Palavras-chave

Versões (2)
  1. 25/08/2017 25/08/2017 -
  2. 08/09/2017 08/09/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de agosto 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.

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

Inglês

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulários  
General information
Descrição

General information

Protocol identifier
Descrição

Protocol identifier

Tipo de dados

text

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Descrição

Visit Description

Tipo de dados

text

Pregnancy information
Descrição

Pregnancy information

Did the subject become pregnant during the study?
Descrição

If Yes, complete Pregnancy Notification form.

Tipo de dados

text

Study conclusion
Descrição

Study conclusion

Date of subject completion or withdrawal
Descrição

Date

Tipo de dados

date

Was the subject withdrawn from the study?
Descrição

Withdrawal

Tipo de dados

boolean

If Yes, check the primary reason for withdrawal:
Descrição

reason withdrawal

Tipo de dados

text

If other reason, specify
Descrição

other reason withdrawal

Tipo de dados

text

Investigator comment log
Descrição

Investigator comment log

CRF page number if applicable
Descrição

CRF page number

Tipo de dados

integer

Comment
Descrição

Comment

Tipo de dados

text

Investigator's signature
Descrição

Investigator's signature

Investigator’s Signature
Descrição

Investigator Signature

Tipo de dados

text

Date
Descrição

signature date

Tipo de dados

date

Investigator’s name (print)
Descrição

Investigator name

Tipo de dados

text

Voltar ao início da página

Similar models

Study conclusion 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
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
Item Group
Pregnancy information
Item
Did the subject become pregnant during the study?
text
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (x)
Item Group
Study conclusion
Date
Item
Date of subject completion or withdrawal
date
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
Item
If Yes, check the primary reason for withdrawal:
text
reason withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Dyskinesia (28)
CL Item
Other (Z)
other reason withdrawal
Item
If other reason, specify
text
Item Group
Investigator comment log
CRF page number
Item
CRF page number if applicable
integer
Comment
Item
Comment
text
Item Group
Investigator's signature
Investigator Signature
Item
Investigator’s Signature
text
signature date
Item
Date
date
Investigator name
Item
Investigator’s name (print)
text
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