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43689

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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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  1. 01/10/2017 01/10/2017 -
  2. 20/09/2021 20/09/2021 -
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20 septembre 2021

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

    Anglais

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

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient Initials
    Description

    patient's initials

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Patient No.
    Description

    patient number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    INCLUSION CRITERIA
    Description

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    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.
    Description

    adults without childbearing potential

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0001675 (Adult)
    SNOMED
    133936004
    LOINC
    LA13524-6
    UMLS CUI [1,2]
    C3831118 (Childbearing Potential)
    Diagnosis of idiopathic Parkinson's disease according to Hoehn & Yahr Stage I-III based on medical history and neurological examination.
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567 (Parkinson Disease)
    SNOMED
    49049000
    UMLS CUI [1,2]
    C0451215 (Hoehn and Yahr grades)
    Candidate for dopaminergic therapy and warrants/requires dopaminergic therapy.
    Description

    candidate and authorization for dopaminergic therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013036 (Dopaminergic Agents)
    UMLS CUI [1,2]
    C0680281 (authorization)
    Written informed consent prior to admission to the study.
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Date informed consent signed
    Description

    date informed consent signed:

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0009797 (Consent Forms)
    Investigator's Signature
    Description

    investigator's signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    If any question is answered YES, was exception approved by Medical Monitor?
    Description

    exception approved by medical monitor

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1708968 (Medical Monitor)
    UMLS CUI [1,2]
    C1705847 (Exception - Property or Attribute)
    name of medical monitor
    Description

    Exception approved by

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    UMLS CUI [1,2]
    C1708968 (Medical Monitor)
    Date of approval
    Description

    date of approval

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2346844 (Approval Date)
    EXCLUSION CRITERIA
    Description

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    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).
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2]
    C0018939 (Hematological Disease)
    SNOMED
    34093004
    UMLS CUI [3]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    UMLS CUI [4]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [5]
    C0014130 (Endocrine System Diseases)
    SNOMED
    362969004
    UMLS CUI [6]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [7]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [8]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    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.
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0151904 (Aspartate Aminotransferase Increased)
    UMLS CUI [2]
    C0151905 (Alanine Aminotransferase Increased)
    UMLS CUI [3]
    C0700225 (Serum creatinine raised)
    SNOMED
    166717003
    UMLS CUI [4]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    UMLS CUI [5]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    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.
    Description

    severe dizziness, syncope or orthostatic hypotension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0012833 (Dizziness)
    SNOMED
    404640003
    LOINC
    LA7428-1
    UMLS CUI [2]
    C0039070 (Syncope)
    SNOMED
    272030005
    LOINC
    MTHU020851
    UMLS CUI [3]
    C0020651 (Hypotension, Orthostatic)
    SNOMED
    28651003
    Significant sleep disorder or screening Epworth Sleep Score~ 9.
    Description

    sleep disorder on Epworth sleep scale

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0851578 (Sleep Disorders)
    SNOMED
    39898005
    UMLS CUI [1,2]
    C3541276 (Epworth Sleepiness Scale Questionnaire)
    SNOMED
    708735004
    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.)
    Description

    L-dopa treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023570 (levodopa)
    SNOMED
    15383004
    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.)
    Description

    dopaminergic therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013036 (Dopaminergic Agents)
    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.
    Description

    hormone replacement therapy, CYP1A2 inducers or CYP1A2 inhibitors

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0282402 (Hormone replacement therapy)
    SNOMED
    266717002
    UMLS CUI [2]
    C3850050 (Cytochrome P-450 CYP1A2 Inducers)
    UMLS CUI [3]
    C3850068 (Cytochrome P-450 CYP1A2 Inhibitors)
    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.
    Description

    hypersensitivity or adverse reactions to ropinirole

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0244821 (ropinirole)
    SNOMED
    108473005
    UMLS CUI [2,1]
    C0559546 (Adverse reactions)
    SNOMED
    281647001
    UMLS CUI [2,2]
    C0244821 (ropinirole)
    SNOMED
    108473005
    Use of any investigational drug within the 30 days or 5 half-lives (whichever is longer) before the start of study dosing.
    Description

    investigational drugs

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    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).
    Description

    drug abuse or abuse of alcohol

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013146 (Drug abuse)
    SNOMED
    26416006
    LOINC
    LP36310-8
    UMLS CUI [2]
    C0085762 (Alcohol abuse)
    SNOMED
    15167005
    LOINC
    LP36309-0
    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.
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,3]
    C2347852 (Concomitant Agent)
    Blood donation within the previous two months.
    Description

    blood donation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0005794 (Blood Donation)
    Pregnancy or lactation
    Description

    pregnancy or lactation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    Investigator's Signature
    Description

    investigator's signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    If any question is answered YES, was exception approved by Medical Monitor?
    Description

    exception approved by medical monitor

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1708968 (Medical Monitor)
    UMLS CUI [1,2]
    C1705847 (Exception - Property or Attribute)
    name of medical monitor
    Description

    Exception approved by

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    UMLS CUI [1,2]
    C1708968 (Medical Monitor)
    Date of approval
    Description

    date of approval

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2346844 (Approval Date)
    Retour au début de la page

    Similar models

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

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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