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43689

Descrição

Inclusion/exclusion criteria Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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Versões (2)
  1. 01/10/2017 01/10/2017 -
  2. 20/09/2021 20/09/2021 -
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gsk

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20 de setembro de 2021

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Creative Commons BY-NC 3.0
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    Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

    Inglês

    Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

    1 Formulários  
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Patient Initials
    Descrição

    patient's initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient No.
    Descrição

    patient number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1830427
    INCLUSION CRITERIA
    Descrição

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693
    Men or women (who are not of childbearing potential, defined as those who have been naturally free of menses for at least 2 years or have undergone hysterectomy or surgical sterilization), age 30 years or older.
    Descrição

    adults without childbearing potential

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001675
    UMLS CUI [1,2]
    C3831118
    Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
    Descrição

    diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0451215
    Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
    Descrição

    candidate and authorization for dopaminergic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013036
    UMLS CUI [1,2]
    C0680281
    Written informed consent prior to admission to the study.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Date informed consent signed
    Descrição

    date informed consent signed:

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0009797
    Investigator's Signature
    Descrição

    investigator's signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    If any question is answered YES, was exception approved by Medical Monitor?
    Descrição

    exception approved by medical monitor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1708968
    UMLS CUI [1,2]
    C1705847
    name of medical monitor
    Descrição

    Exception approved by

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
    Date of approval
    Descrição

    date of approval

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2346844
    EXCLUSION CRITERIA
    Descrição

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251
    Presence - or history within the previous 3 months - of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological, (otherthan Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrythmias, CVA), or active malignancy (other than basal cell cancer).
    Descrição

    psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0018939
    UMLS CUI [3]
    C0022658
    UMLS CUI [4]
    C0023895
    UMLS CUI [5]
    C0014130
    UMLS CUI [6]
    C0027765
    UMLS CUI [7]
    C0007222
    UMLS CUI [8]
    C0006826
    Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
    Descrição

    AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0151904
    UMLS CUI [2]
    C0151905
    UMLS CUI [3]
    C0700225
    UMLS CUI [4]
    C0438215
    UMLS CUI [5]
    C0522055
    Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure (supine, erect) from baseline values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure.
    Descrição

    severe dizziness, syncope or orthostatic hypotension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0012833
    UMLS CUI [2]
    C0039070
    UMLS CUI [3]
    C0020651
    Significant sleep disorder or screening Epworth Sleep Score~ 9.
    Descrição

    sleep disorder on Epworth sleep scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0851578
    UMLS CUI [1,2]
    C3541276
    History of previous treatment with any L-dopa dose or preparation for more than weeks. (L-dopa treatment must be discontinued for at least a 2-week wash-out period before enrollment.)
    Descrição

    L-dopa treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023570
    History of other dopaminergic therapy within two weeks before enrollment. (Note: Patients on dopaminergic therapy may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrollment. Patients on selegiline may be enrolled, but must remain on their current dose during study participation.)
    Descrição

    dopaminergic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013036
    Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially induce CYP1A2 (e.g., ciprofloxacin, fluvoxacine, cimetidine, ethinyloestradiol) or inhibit CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through Day 14.
    Descrição

    hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0282402
    UMLS CUI [2]
    C3850050
    UMLS CUI [3]
    C3850068
    Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure. In particular, patients with inadequate tolerance of ropinirole at doses below 12 mg per day are to be excluded.
    Descrição

    hypersensitivity or adverse reactions to ropinirole

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0244821
    UMLS CUI [2,1]
    C0559546
    UMLS CUI [2,2]
    C0244821
    Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
    Descrição

    investigational drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; one unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
    Descrição

    drug abuse or abuse of alcohol

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013146
    UMLS CUI [2]
    C0085762
    Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
    Descrição

    concern about the patient's compliance behavior and the use of new or prohibited concomitant medications

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0422727
    UMLS CUI [1,3]
    C2347852
    Blood donation within the previous two months.
    Descrição

    blood donation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    Pregnancy or lactation
    Descrição

    pregnancy or lactation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Investigator's Signature
    Descrição

    investigator's signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    If any question is answered YES, was exception approved by Medical Monitor?
    Descrição

    exception approved by medical monitor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1708968
    UMLS CUI [1,2]
    C1705847
    name of medical monitor
    Descrição

    Exception approved by

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
    Date of approval
    Descrição

    date of approval

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2346844
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    Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    patient's initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    patient number
    Item
    Patient No.
    integer
    C1830427 (UMLS CUI [1])
    Item Group
    INCLUSION CRITERIA
    C1512693 (UMLS CUI-1)
    adults without childbearing potential
    Item
    Men or women (who are not of childbearing potential, defined as those who have been naturally free of menses for at least 2 years or have undergone hysterectomy or surgical sterilization), age 30 years or older.
    boolean
    C0001675 (UMLS CUI [1,1])
    C3831118 (UMLS CUI [1,2])
    diagnosis of Parkinson's disease according to Hoehn&Yahr Stage I-III
    Item
    Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
    boolean
    C0030567 (UMLS CUI [1,1])
    C0451215 (UMLS CUI [1,2])
    candidate and authorization for dopaminergic therapy
    Item
    Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
    boolean
    C0013036 (UMLS CUI [1,1])
    C0680281 (UMLS CUI [1,2])
    informed consent
    Item
    Written informed consent prior to admission to the study.
    boolean
    C0021430 (UMLS CUI [1])
    date informed consent signed:
    Item
    Date informed consent signed
    date
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    investigator's signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    exception approved by medical monitor
    Item
    If any question is answered YES, was exception approved by Medical Monitor?
    boolean
    C1708968 (UMLS CUI [1,1])
    C1705847 (UMLS CUI [1,2])
    name of medical monitor
    Item
    name of medical monitor
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    date of approval
    Item
    Date of approval
    date
    C2346844 (UMLS CUI [1])
    Item Group
    EXCLUSION CRITERIA
    C0680251 (UMLS CUI-1)
    psychiatric, hematological, renal, hepatic, endocrinological, neurological or cardiovascular diseases or active malignancy
    Item
    Presence - or history within the previous 3 months - of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological, (otherthan Parkinson's disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrythmias, CVA), or active malignancy (other than basal cell cancer).
    boolean
    C0004936 (UMLS CUI [1])
    C0018939 (UMLS CUI [2])
    C0022658 (UMLS CUI [3])
    C0023895 (UMLS CUI [4])
    C0014130 (UMLS CUI [5])
    C0027765 (UMLS CUI [6])
    C0007222 (UMLS CUI [7])
    C0006826 (UMLS CUI [8])
    AST or ALT or serum creatinine increased or other clinically significant laboratory or ECG abnormalities
    Item
    Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    C0700225 (UMLS CUI [3])
    C0438215 (UMLS CUI [4])
    C0522055 (UMLS CUI [5])
    severe dizziness, syncope or orthostatic hypotension
    Item
    Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure (supine, erect) from baseline values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure.
    boolean
    C0012833 (UMLS CUI [1])
    C0039070 (UMLS CUI [2])
    C0020651 (UMLS CUI [3])
    sleep disorder on Epworth sleep scale
    Item
    Significant sleep disorder or screening Epworth Sleep Score~ 9.
    boolean
    C0851578 (UMLS CUI [1,1])
    C3541276 (UMLS CUI [1,2])
    L-dopa treatment
    Item
    History of previous treatment with any L-dopa dose or preparation for more than weeks. (L-dopa treatment must be discontinued for at least a 2-week wash-out period before enrollment.)
    boolean
    C0023570 (UMLS CUI [1])
    dopaminergic therapy
    Item
    History of other dopaminergic therapy within two weeks before enrollment. (Note: Patients on dopaminergic therapy may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrollment. Patients on selegiline may be enrolled, but must remain on their current dose during study participation.)
    boolean
    C0013036 (UMLS CUI [1])
    hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors
    Item
    Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially induce CYP1A2 (e.g., ciprofloxacin, fluvoxacine, cimetidine, ethinyloestradiol) or inhibit CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to enrollment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through Day 14.
    boolean
    C0282402 (UMLS CUI [1])
    C3850050 (UMLS CUI [2])
    C3850068 (UMLS CUI [3])
    hypersensitivity or adverse reactions to ropinirole
    Item
    Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure. In particular, patients with inadequate tolerance of ropinirole at doses below 12 mg per day are to be excluded.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0244821 (UMLS CUI [1,2])
    C0559546 (UMLS CUI [2,1])
    C0244821 (UMLS CUI [2,2])
    investigational drugs
    Item
    Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
    boolean
    C0013230 (UMLS CUI [1])
    drug abuse or abuse of alcohol
    Item
    Recent history, or suspicion, of drug dependence or abuse of alcohol (with alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; one unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine).
    boolean
    C0013146 (UMLS CUI [1])
    C0085762 (UMLS CUI [2])
    concern about the patient's compliance behavior and the use of new or prohibited concomitant medications
    Item
    Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0422727 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    blood donation
    Item
    Blood donation within the previous two months.
    boolean
    C0005794 (UMLS CUI [1])
    pregnancy or lactation
    Item
    Pregnancy or lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    investigator's signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    exception approved by medical monitor
    Item
    If any question is answered YES, was exception approved by Medical Monitor?
    boolean
    C1708968 (UMLS CUI [1,1])
    C1705847 (UMLS CUI [1,2])
    name of medical monitor
    Item
    name of medical monitor
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    date of approval
    Item
    Date of approval
    date
    C2346844 (UMLS CUI [1])
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