0 Ratings
ID

36011

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Alcohol Consumption and Smoking History form. It has to be filled in for screening.

Keywords

Versions (5)
  1. 8/29/17 8/29/17 -
  2. 9/5/17 9/5/17 -
  3. 9/6/17 9/6/17 -
  4. 10/5/17 10/5/17 -
  5. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2019

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License

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Alcohol Consumption, Smoking History

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Alcohol Consumption
    Description

    Alcohol Consumption

    Alias
    UMLS CUI-1
    C0001948
    Average number of units per day
    Description

    1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0560578
    Average number of units per week
    Description

    1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0560579
    Smoking History
    Description

    Smoking History

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

    if Yes, please complete the itemgroup "smoking history details"

    Data type

    text

    Alias
    UMLS CUI [1]
    C0543414
    Smoking history details
    Description

    Smoking history details

    Alias
    UMLS CUI-1
    C0543414
    UMLS CUI-2
    C1522508
    Number of years the subject has been a smoker?
    Description

    Smoking years

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1,1]
    C0037369
    UMLS CUI [1,2]
    C0439234
    UMLS CUI [1,3]
    C0449788
    years
    Average number of cigarettes smoked per day?
    Description

    Cigarettes per day

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3694146
    Please state what type of tobacco product
    Description

    (eg. pipe, chigar, chewing tobacco or cigarette)

    Data type

    text

    Alias
    UMLS CUI [1]
    C3166496
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    Similar models

    Alcohol Consumption, Smoking History

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Alcohol Consumption
    C0001948 (UMLS CUI-1)
    Units per day
    Item
    Average number of units per day
    integer
    C0560578 (UMLS CUI [1])
    Units per week
    Item
    Average number of units per week
    integer
    C0560579 (UMLS CUI [1])
    Item Group
    Smoking History
    C1519384 (UMLS CUI-1)
    Item
    Is the subject a smoker?
    text
    C0543414 (UMLS CUI [1])
    Smoker
    Code List
    Is the subject a smoker?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Smoking history details
    C0543414 (UMLS CUI-1)
    C1522508 (UMLS CUI-2)
    Smoking years
    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])
    Cigarettes per day
    Item
    Average number of cigarettes smoked per day?
    integer
    C3694146 (UMLS CUI [1])
    Type of tobacco product
    Item
    Please state what type of tobacco product
    text
    C3166496 (UMLS CUI [1])
    Back to the top of the page 

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