ID

40520

Beschrijving

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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Versies (3)
  1. 24/04/2020 24/04/2020 -
  2. 30/04/2020 30/04/2020 -
  3. 08/05/2020 08/05/2020 -
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GlaxoSmithKline

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30 de abril de 2020

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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    Engels

    Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

    1 Formulieren  
    Patient administration
    Beschrijving

    Patient administration

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beschrijving

    Centre Number

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Beschrijving

    Visit Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Smoking History
    Beschrijving

    Smoking History

    Alias
    UMLS CUI-1
    C1519384
    Is the subject a smoker?
    Beschrijving

    If yes, please complete smoking history details.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    Number of years the subject has been a smoker?
    Beschrijving

    Number of years the subject has been a smoker?

    Datatype

    integer

    Maateenheden
    • Yrs
    Alias
    UMLS CUI [1,1]
    C0037369
    UMLS CUI [1,2]
    C0439234
    UMLS CUI [1,3]
    C0449788
    Yrs
    Average number of cigarettes smoked per day?
    Beschrijving

    Average number of cigarettes smoked per day?

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1608325
    Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
    Beschrijving

    Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3166496
    UMLS CUI [2]
    C0678447
    UMLS CUI [3]
    C0678446
    UMLS CUI [4]
    C0241410
    UMLS CUI [5]
    C0677453
    RLS Pharmacotherapy History
    Beschrijving

    RLS Pharmacotherapy History

    Alias
    UMLS CUI-1
    C0013216
    UMLS CUI-2
    C0035258
    Has the patient taken any pharmacotherapy medication for treatment of RLS?
    Beschrijving

    If yes, please record details below.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    RLS Pharmacotherapy History
    Beschrijving

    RLS Pharmacotherapy History

    Alias
    UMLS CUI-1
    C0013216
    UMLS CUI-2
    C0035258
    RLS Pharmacotherapy - Drug Name
    Beschrijving

    Trade Name Preferred

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [2]
    C2360065
    RLS Pharmacotherapy - Start Date
    Beschrijving

    be as precise as possible

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [1,3]
    C0808070
    RLS Pharmacotherapy - End date
    Beschrijving

    RLS Pharmacotherapy - End date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [1,3]
    C0806020
    RLS Pharmacotherapy - Continuing
    Beschrijving

    RLS Pharmacotherapy - Continuing

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [1,3]
    C0549178
    RLS Pharmacotherapy - Did the patient respond to the treatment?
    Beschrijving

    RLS Pharmacotherapy - Did the patient respond to the treatment?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [2]
    C0521982
    RLS Pharmacotherapy - Did the patient tolerate the treatment?
    Beschrijving

    RLS Pharmacotherapy - Did the patient tolerate the treatment?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0035258
    UMLS CUI [2]
    C0013220
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Vital Signs - Date and Time
    Beschrijving

    Vital Signs - Date and Time

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Vital Signs - Semi-supine BP Systolic
    Beschrijving

    Vital Signs - Semi-supine BP Systolic

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0871470
    UMLS CUI [2,2]
    C0522019
    mm[Hg]
    Vital Signs - Semi-supine BP Diastolic
    Beschrijving

    Vital Signs - Semi-supine BP Diastolic

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0428883
    UMLS CUI [2,2]
    C0522019
    mm[Hg]
    Vital Signs - Semi-supine Hear Rate
    Beschrijving

    Vital Signs - Semi-supine Hear Rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0018810
    UMLS CUI [2,2]
    C0522019
    beats/min
    Vital Signs - Time
    Beschrijving

    Vital Signs - Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Vital Signs - Erect BP Systolic
    Beschrijving

    Vital Signs - Erect BP Systolic

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0871470
    UMLS CUI [2,2]
    C0522014
    mm[Hg]
    Vital Signs - Erect BP Diastolic
    Beschrijving

    Vital Signs - Erect BP Diastolic

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0428883
    UMLS CUI [2,2]
    C0522014
    mm[Hg]
    Vital Signs - Erect Heart Rate
    Beschrijving

    Vital Signs - Erect Heart Rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2,1]
    C0018810
    UMLS CUI [2,2]
    C0522014
    beats/min
    12 Lead ECG Monitoring
    Beschrijving

    12 Lead ECG Monitoring

    Alias
    UMLS CUI-1
    C0430456
    12 Lead ECG Monitoring - Date
    Beschrijving

    12 Lead ECG Monitoring - Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    12 Lead ECG Monitoring - Actual Time
    Beschrijving

    12 Lead ECG Monitoring - Actual Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0040223
    12 Lead ECG Monitoring - Heart Rate
    Beschrijving

    12 Lead ECG Monitoring - Heart Rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0018810
    beats/min
    12 Lead ECG Monitoring - PR
    Beschrijving

    12 Lead ECG Monitoring - PR

    Datatype

    integer

    Maateenheden
    • ms
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    ms
    12 Lead ECG Monitoring - QRS
    Beschrijving

    12 Lead ECG Monitoring - QRS

    Datatype

    integer

    Maateenheden
    • ms
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    ms
    12 Lead ECG Monitoring - QTC
    Beschrijving

    12 Lead ECG Monitoring - QTC

    Datatype

    integer

    Maateenheden
    • ms
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0489625
    ms
    12 Lead ECG Monitoring - ECG clinically significant?
    Beschrijving

    12 Lead ECG Monitoring - ECG clinically significant?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2826293
    12 Lead ECG Monitoring - Comments
    Beschrijving

    12 Lead ECG Monitoring - Comments

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0947611
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    Similar models

    Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Patient administration
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Smoking History
    C1519384 (UMLS CUI-1)
    Is the subject a smoker?
    Item
    Is the subject a smoker?
    boolean
    C1519386 (UMLS CUI [1])
    Number of years the subject has been a smoker?
    Item
    Number of years the subject has been a smoker?
    integer
    C0037369 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Average number of cigarettes smoked per day?
    Item
    Average number of cigarettes smoked per day?
    integer
    C1608325 (UMLS CUI [1])
    Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
    Item
    Please state what type of tobacco product (eg. pipe, cigar, chewing tobacco or cigarette)
    text
    C3166496 (UMLS CUI [1])
    C0678447 (UMLS CUI [2])
    C0678446 (UMLS CUI [3])
    C0241410 (UMLS CUI [4])
    C0677453 (UMLS CUI [5])
    Item Group
    RLS Pharmacotherapy History
    C0013216 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    Has the patient taken any pharmacotherapy medication for treatment of RLS?
    Item
    Has the patient taken any pharmacotherapy medication for treatment of RLS?
    boolean
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    RLS Pharmacotherapy History
    C0013216 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    RLS Pharmacotherapy - Drug Name
    Item
    RLS Pharmacotherapy - Drug Name
    text
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [2])
    RLS Pharmacotherapy - Start Date
    Item
    RLS Pharmacotherapy - Start Date
    date
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    RLS Pharmacotherapy - End date
    Item
    RLS Pharmacotherapy - End date
    date
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Item
    RLS Pharmacotherapy - Continuing
    integer
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    RLS Pharmacotherapy - Continuing
    Code List
    RLS Pharmacotherapy - Continuing
    CL Item
    Continuing (1)
    Item
    RLS Pharmacotherapy - Did the patient respond to the treatment?
    text
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0521982 (UMLS CUI [2])
    RLS Pharmacotherapy - Did the patient respond to the treatment?
    Code List
    RLS Pharmacotherapy - Did the patient respond to the treatment?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (Unk)
    Item
    RLS Pharmacotherapy - Did the patient tolerate the treatment?
    text
    C0013216 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    C0013220 (UMLS CUI [2])
    RLS Pharmacotherapy - Did the patient tolerate the treatment?
    Code List
    RLS Pharmacotherapy - Did the patient tolerate the treatment?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (Unk)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs - Date and Time
    Item
    Vital Signs - Date and Time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Vital Signs - Semi-supine BP Systolic
    Item
    Vital Signs - Semi-supine BP Systolic
    integer
    C0518766 (UMLS CUI [1])
    C0871470 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Semi-supine BP Diastolic
    Item
    Vital Signs - Semi-supine BP Diastolic
    integer
    C0518766 (UMLS CUI [1])
    C0428883 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Semi-supine Hear Rate
    Item
    Vital Signs - Semi-supine Hear Rate
    integer
    C0518766 (UMLS CUI [1])
    C0018810 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    Vital Signs - Time
    Item
    Vital Signs - Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Vital Signs - Erect BP Systolic
    Item
    Vital Signs - Erect BP Systolic
    integer
    C0518766 (UMLS CUI [1])
    C0871470 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Vital Signs - Erect BP Diastolic
    Item
    Vital Signs - Erect BP Diastolic
    integer
    C0518766 (UMLS CUI [1])
    C0428883 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Vital Signs - Erect Heart Rate
    Item
    Vital Signs - Erect Heart Rate
    integer
    C0518766 (UMLS CUI [1])
    C0018810 (UMLS CUI [2,1])
    C0522014 (UMLS CUI [2,2])
    Item Group
    12 Lead ECG Monitoring
    C0430456 (UMLS CUI-1)
    12 Lead ECG Monitoring - Date
    Item
    12 Lead ECG Monitoring - Date
    date
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - Actual Time
    Item
    12 Lead ECG Monitoring - Actual Time
    time
    C0430456 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - Heart Rate
    Item
    12 Lead ECG Monitoring - Heart Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - PR
    Item
    12 Lead ECG Monitoring - PR
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - QRS
    Item
    12 Lead ECG Monitoring - QRS
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - QTC
    Item
    12 Lead ECG Monitoring - QTC
    integer
    C0430456 (UMLS CUI [1,1])
    C0489625 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - ECG clinically significant?
    Item
    12 Lead ECG Monitoring - ECG clinically significant?
    boolean
    C0430456 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    12 Lead ECG Monitoring - Comments
    Item
    12 Lead ECG Monitoring - Comments
    text
    C0430456 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
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