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29075

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)

Transferido a

23 de fevereiro de 2018

DOI

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Licença

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

    Scales, baseline signs and symptoms

    1 Formulários  
    Scales RLS
    Descrição

    Scales RLS

    Alias
    UMLS CUI-1
    C0450973
    UMLS CUI-2
    C0035258
    Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
    Descrição

    IRLS Rating Scale

    Tipo de dados

    integer

    Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
    Descrição

    If the patient is eligible to continue in the study please continue the assessments for this visit as stated below:

    Tipo de dados

    boolean

    Vital signs
    Descrição

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Pulse (after 5 minutes sitting)
    Descrição

    Pulse

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
    Descrição

    Blood pressure

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Descrição

    Concomitant medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Descrição

    Medical Procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0199171
    Baseline signs and symptoms
    Descrição

    Baseline signs and symptoms

    Alias
    UMLS CUI-1
    C0037088
    If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
    Descrição

    Serious baseline events

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Please mark this box if no baseline events occurred prior to randomisation into study.
    Descrição

    Baseline events

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Baseline signs and symptoms
    Descrição

    Baseline signs and symptoms

    Alias
    UMLS CUI-1
    C0037088
    Onset Date and Time
    Descrição

    Onset Date and Time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C2826806
    End Date and Time (If ongoing please leave blank)
    Descrição

    End Date and Time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    Descrição

    Outcome

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Event Course
    Descrição

    Event Course

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    Event Course, if 'intermittent' please specify No. of episodes:
    Descrição

    Event Course

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    Intensity (maximum)
    Descrição

    INTENSITY (Maximum) MILD An event which is easily tolerated MODERATE An event which is sufficiently discomforting to interfere with daily activities SEVERE An event which prevents normal everyday activities

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Relationship to study procedures performed prior to randomisation
    Descrição

    RELATIONSHIP TO STUDY PROCEDURES RELATED There is a direct cause and effect relationship between the event and the study procedures POSSIBLY RELATED A direct cause and effect relationship between the study procedures and the event has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the study procedures and the event has not been demonstrated, is improbable but not impossible UNRELATED The event is definitely not related to the study procedures

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1510821
    Corrective Therapy
    Descrição

    If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific event?
    Descrição

    Withdrawal related to adverse event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0877248
    Ramos Randomisation and Dispensing
    Descrição

    Ramos Randomisation and Dispensing

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0947323
    Randomisation number:
    Descrição

    Randomisation number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Container numbers:
    Descrição

    Container numbers

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0180098
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0518766
    Reading
    Descrição

    Reading

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0034754
    Time of dose
    Descrição

    Time of dose

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    Time Vitals Taken
    Descrição

    Time Vitals Taken

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Blood pressure systolic/diastolic
    Descrição

    Blood pressure

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse
    Descrição

    Pulse

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
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    Similar models

    Scales, baseline signs and symptoms

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Scales RLS
    C0450973 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    IRLS Rating Scale
    Item
    Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
    integer
    Patient rated scales
    Item
    Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
    boolean
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Pulse
    Item
    Pulse (after 5 minutes sitting)
    integer
    C0232117 (UMLS CUI [1])
    Blood pressure
    Item
    Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
    integer
    C0005823 (UMLS CUI [1])
    Concomitant medication
    Item
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    boolean
    C2347852 (UMLS CUI [1])
    Medical Procedures
    Item
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    boolean
    C0199171 (UMLS CUI [1])
    Item Group
    Baseline signs and symptoms
    C0037088 (UMLS CUI-1)
    Serious baseline events
    Item
    If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
    boolean
    C1519255 (UMLS CUI [1])
    Baseline events
    Item
    Please mark this box if no baseline events occurred prior to randomisation into study.
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Baseline signs and symptoms
    C0037088 (UMLS CUI-1)
    Onset Date and Time
    Item
    Onset Date and Time
    datetime
    C2826806 (UMLS CUI [1])
    End Date and Time
    Item
    End Date and Time (If ongoing please leave blank)
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    CL Item
    [1] Resolved (1)
    CL Item
    [2] Ongoing (2)
    CL Item
    [3] Died (3)
    Item
    Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Event Course
    Code List
    Event Course
    CL Item
    [1] Intermittent (1)
    CL Item
    [2] Constant (2)
    Event Course
    Item
    Event Course, if 'intermittent' please specify No. of episodes:
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1])
    Intensity
    Code List
    Intensity (maximum)
    CL Item
    [1] Mild (1)
    CL Item
    [2] Moderate (2)
    CL Item
    [3] Severe (3)
    Item
    Relationship to study procedures performed prior to randomisation
    integer
    C1510821 (UMLS CUI [1])
    Relationship to study procedures
    Code List
    Relationship to study procedures performed prior to randomisation
    CL Item
    [5] Related (1)
    CL Item
    [6] Possibly related (2)
    CL Item
    [7] Probably unrelated (3)
    CL Item
    [1] Unrelated (4)
    Corrective Therapy
    Item
    Corrective Therapy
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Withdrawal related to adverse event
    Item
    Was patient withdrawn due to this specific event?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item Group
    Ramos Randomisation and Dispensing
    C0034656 (UMLS CUI-1)
    C0947323 (UMLS CUI-2)
    Randomisation number
    Item
    Randomisation number:
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Container numbers
    Item
    Container numbers:
    integer
    C0180098 (UMLS CUI [1])
    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)
    Item
    Reading
    integer
    C0456984 (UMLS CUI [1,1])
    C0034754 (UMLS CUI [1,2])
    Reading
    Code List
    Reading
    CL Item
    Pre-Dose Reading (1)
    CL Item
    2 hours Post-Dose Reading (2)
    Time of dose
    Item
    Time of dose
    time
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Time Vitals Taken
    Item
    Time Vitals Taken
    date
    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])
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