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29077

Descrição

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

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Versões (1)
  1. 23/02/2018 23/02/2018 -
Titular dos direitos

GlaxoSmithKline (GSK)

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23 de fevereiro de 2018

DOI

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Creative Commons BY-NC 3.0
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    Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

    Inglês

    Assessment Week1

    1 Formulários  
    1. StudyEvent: ODM
      1. Assessment Week1
    Administration
    Descrição

    Administration

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient number
    Descrição

    Patient number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Visit date
    Descrição

    Visit date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Center Number
    Descrição

    Center Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    IRLS Rating Scale
    Descrição

    IRLS Rating Scale

    Alias
    UMLS CUI-1
    C0681889 (rating scale)
    UMLS CUI-2
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Please complete the IRLS Rating Scale
    Descrição

    IRLS Rating Scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0681889 (rating scale)
    UMLS CUI [1,2]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Time Vitals Taken
    Descrição

    Time Vitals Taken

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic/diastolic
    Descrição

    Blood pressure

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Pulse
    Descrição

    Pulse

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    beats/min
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Descrição

    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.

    Alias
    UMLS CUI-1
    C0199171 (Medical procedure)
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Descrição

    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    Descrição

    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Clinical Global Impressions
    Descrição

    Clinical Global Impressions

    Alias
    UMLS CUI-1
    C3639708 (Clinical global impression scale)
    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
    Descrição

    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.

    Alias
    UMLS CUI-1
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI-2
    C0547047 (Decrease)
    SNOMED
    260370003
    Ramos Dispensing
    Descrição

    Ramos Dispensing

    Alias
    UMLS CUI-1
    C0034656 (Randomization)
    UMLS CUI-2
    C0947323 (Dispensing medication)
    SNOMED
    373784005
    Container Numbers:
    Descrição

    Container numbers

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0180098 (Containers)
    SNOMED
    706437002
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    Similar models

    Assessment Week1

    1 Formulários
    1. StudyEvent: ODM
      1. Assessment Week1
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient number
    integer
    C1830427 (UMLS CUI [1])
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    IRLS Rating Scale
    C0681889 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    IRLS Rating Scale
    Item
    Please complete the IRLS Rating Scale
    boolean
    C0681889 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Orthostatic vital signs
    C0518766 (UMLS CUI-1)
    Item
    Orthostatic vital signs
    integer
    C0518766 (UMLS CUI [1])
    Orthostatic vital signs
    Code List
    Orthostatic vital signs
    CL Item
    After 10 minutes semi-supine (1)
    CL Item
    After erect for 1 minute (2)
    Time Vitals Taken
    Item
    Time Vitals Taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood pressure
    Item
    Blood pressure systolic/diastolic
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    C0199171 (UMLS CUI-1)
    Item Group
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    C2347852 (UMLS CUI-1)
    Item Group
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    C0877248 (UMLS CUI-1)
    Item Group
    Clinical Global Impressions
    C3639708 (UMLS CUI-1)
    Item Group
    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
    C0178602 (UMLS CUI-1)
    C0547047 (UMLS CUI-2)
    Item Group
    Ramos Dispensing
    C0034656 (UMLS CUI-1)
    C0947323 (UMLS CUI-2)
    Container numbers
    Item
    Container Numbers:
    integer
    C0180098 (UMLS CUI [1])
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