ID

24041

Descrição

Module 1 - Enrolment - Previous study information and eligibility 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Palavras-chave

Versões (1)
  1. 23/07/2017 23/07/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

23 de julho de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

Inglês

GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

1 Formulários  
Previous study information
Descrição

Previous study information

Alias
UMLS CUI-1
C2603343
UMLS CUI-2
C1533716
UMLS CUI-3
C0205156
Visite date
Descrição

visit date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Previous SB Protocol Number
Descrição

Previous Protocol Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0205156
Previous Centre Number
Descrição

previous centre number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0019994
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0205156
Previous Patient Number
Descrição

The patient number used in the previous study should match the patient number on the header of this page.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1830427
UMLS CUI [1,2]
C0205156
Please complete the following inclusion criteria
Descrição

Please complete the following inclusion criteria

Alias
UMLS CUI-1
C1512693
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
Descrição

Subject completed previous study

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0205156
The subject must have given written informed consent prior to any specific study procedures
Descrição

written informed consent

Tipo de dados

integer

Alias
UMLS CUI [1]
C0021430
Please complete the following exclusion criteria.
Descrição

Please complete the following exclusion criteria.

Alias
UMLS CUI-1
C0680251
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
Descrição

childbearing potential and no contraception

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Women who have a positive pregnancy test.
Descrição

pregnancy test positive

Tipo de dados

integer

Alias
UMLS CUI [1]
C0240802
Subjects who have developed any medically unstable illnesses
Descrição

unstable health condition

Tipo de dados

integer

Alias
UMLS CUI [1]
C4062077
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Previous study information
C2603343 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
visit date
Item
Visite date
date
C1320303 (UMLS CUI [1])
Previous Protocol Number
Item
Previous SB Protocol Number
text
C2348563 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
previous centre number
Item
Previous Centre Number
text
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Patient Number
Item
Previous Patient Number
text
C1830427 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Please complete the following inclusion criteria
C1512693 (UMLS CUI-1)
Item
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
integer
C2348577 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Subject completed previous study
Code List
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
CL Item
yes (1 )
CL Item
no (2 )
Item
The subject must have given written informed consent prior to any specific study procedures
integer
C0021430 (UMLS CUI [1])
written informed consent
Code List
The subject must have given written informed consent prior to any specific study procedures
CL Item
yes (1 )
CL Item
no (2 )
Item Group
Please complete the following exclusion criteria.
C0680251 (UMLS CUI-1)
Item
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
integer
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
childbearing potential and no contraception
Code List
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
CL Item
yes (1 )
CL Item
no (2 )
Item
Women who have a positive pregnancy test.
integer
C0240802 (UMLS CUI [1])
pregnancy test positive
Code List
Women who have a positive pregnancy test.
CL Item
yes (1 )
CL Item
no (2 )
Item
Subjects who have developed any medically unstable illnesses
integer
C4062077 (UMLS CUI [1])
unstable health condition
Code List
Subjects who have developed any medically unstable illnesses
CL Item
yes (1 )
CL Item
no (2 )
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