0 Evaluaciones
ID

24041

Descripción

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

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Versiones (1)
  1. 23/7/17 23/7/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de julio de 2017

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Previous study information
    Descripción

    Previous study information

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

    visit date

    Tipo de datos

    date

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

    Previous Protocol Number

    Tipo de datos

    text

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

    previous centre number

    Tipo de datos

    text

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

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

    Tipo de datos

    text

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

    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
    Descripción

    Subject completed previous study

    Tipo de datos

    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
    Descripción

    written informed consent

    Tipo de datos

    integer

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

    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*).
    Descripción

    childbearing potential and no contraception

    Tipo de datos

    integer

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

    pregnancy test positive

    Tipo de datos

    integer

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

    unstable health condition

    Tipo de datos

    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 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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