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44150

Descrição

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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

Palavras-chave

Versões (3)
  1. 24/09/2017 24/09/2017 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  3. 20/09/2021 20/09/2021 -
Titular dos direitos

glaxoSmithKline

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0
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    Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    Inglês

    Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Men or women 30 to 85 years of age, inclusive, at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraception [i.e. Norplant System]), during the study and for at least one month prior to randomization and one month following completion of the study.
    Descrição

    age and child-bearing potential contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1960468
    UMLS CUI [1,3]
    C0700589
    Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
    Descrição

    idiopathic Parkinson's disease Hoehn&Yahr Stage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0865475
    UMLS CUI [1,2]
    C3639483
    Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
    Descrição

    study subject participation status ropinirole or candidate for dopaminergic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0244821
    UMLS CUI [2]
    C3267134
    Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
    Descrição

    bmi

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    If any question is answered NO, was exemption approved by Medical Monitor?
    Descrição

    exemption approved

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0585836
    UMLS CUI [1,2]
    C1708968
    Approved by
    Descrição

    Medical monitor name

    Tipo de dados

    text

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

    Date of approval

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2346844
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
    Descrição

    physical examination abnormality

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [2]
    C0035648
    Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson s disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident [CVA]), or active malignancy (other than basal cell cancer).
    Descrição

    psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease 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 [5,1]
    C0014130
    UMLS CUI [5,2]
    C0027765
    UMLS CUI [6]
    C0007222
    UMLS CUI [7]
    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

    laboratory abnormality or ECG abnormalities

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    UMLS CUI [2]
    C0522055
    Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
    Descrição

    Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0019168
    UMLS CUI [1,2]
    C0166049
    UMLS CUI [2]
    C0019683
    Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
    Descrição

    alcohol breath test or blood test and/or urine drugs of abuse test at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1710477
    UMLS CUI [1,3]
    C1167994
    UMLS CUI [1,4]
    C1710477
    UMLS CUI [2,1]
    C0451130
    UMLS CUI [2,2]
    C1710477
    Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
    Descrição

    syncope or orthostatic hypotension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020651
    UMLS CUI [2,1]
    C0039070
    UMLS CUI [2,2]
    C0262926
    Significant sleep disorder or screening Epworth Sleep Score 39.
    Descrição

    sleep disorder or Epworth Sleep Score 39

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0851578
    UMLS CUI [1,2]
    C2129304
    Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
    Descrição

    Abnormal diastolic arterial pressure or abnormal systolic arterial pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0277888
    UMLS CUI [2]
    C0277883
    Currently receiving any L-dopa dose or preparation.
    Descrição

    L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0023570
    History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
    Descrição

    Note: Patients on dopaminergic agonists other than ropinirole CR may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrolment. Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013036
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0262926
    Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
    Descrição

    hormone replacement therapy or CYP1A2 inhibitors or inducers

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3850050
    UMLS CUI [2]
    C3850068
    UMLS CUI [3]
    C0282402
    Blood donation or significant blood loss less than 90 days before the present study.
    Descrição

    Blood donation or significant blood loss

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005795
    UMLS CUI [2]
    C3163616
    Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
    Descrição

    personal history, or family history, of adverse reactions or hypersensitivity to ropinirole

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0244821
    UMLS CUI [1,3]
    C0241889
    UMLS CUI [1,4]
    C0559546
    UMLS CUI [1,5]
    C0244821
    UMLS CUI [1,6]
    C0241889
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0244821
    UMLS CUI [2,3]
    C0332119
    UMLS CUI [3,1]
    C0559546
    UMLS CUI [3,2]
    C0244821
    UMLS CUI [3,3]
    C0332119
    Use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing.
    Descrição

    Use of any investigational drug

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descrição

    over-the-counter (OTC) medicine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2709201
    UMLS CUI [1,2]
    C0013227
    Recent history, or suspicion, of drug dependence or abuse of alcohol.
    Descrição

    With alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1510472
    UMLS CUI [1,2]
    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

    drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1321605
    Women who are pregnant or breast-feeding
    Descrição

    pregnant or breast-feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    If any question is answered NO, was exemption approved by Medical Monitor?
    Descrição

    exemption approved

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0585836
    UMLS CUI [1,2]
    C1708968
    Approved by
    Descrição

    Medical monitor name

    Tipo de dados

    text

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

    Date of approval

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2346844
    Demographics
    Descrição

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Date of birth
    Descrição

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Descrição

    Sex

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Descrição

    Race

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Please specify other racial group.
    Descrição

    Other race specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Medical history
    Descrição

    Medical history

    Alias
    UMLS CUI-1
    C0262926
    Body system
    Descrição

    Body system

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1268086
    UMLS CUI [1,2]
    C0449913
    Body system
    Descrição

    Body system abnormality

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0460002
    UMLS CUI [1,2]
    C1704258
    Describe abnormality
    Descrição

    Describe abnormality body system

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0459424
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C0678257
    Surgical history: Parkinson's disease
    Descrição

    Surgical history: Parkinson's disease

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0455610
    Surgical Procedures related to Parkinson's Disease
    Descrição

    If yes, please specify.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0455610
    Date
    Descrição

    Date of surgical procedure Parkinson's disease

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0030567
    Procedure
    Descrição

    Surgical procedure Parkinson's disease

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0030567
    Allergies
    Descrição

    Allergies

    Alias
    UMLS CUI-1
    C0020517
    Allergies
    Descrição

    If yes, please specify.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    Allergen
    Descrição

    Allergen

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0002092
    Reaction
    Descrição

    Allergic reaction

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1527304
    Parkinson's disease history
    Descrição

    Parkinson's disease history

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0262926
    Date of Onset of Symptoms of Parkinson's Disease
    Descrição

    Date of Onset Parkinson's Disease

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0574845
    12-lead electrocardiogram report
    Descrição

    12-lead electrocardiogram report

    Alias
    UMLS CUI-1
    C0430456
    Actual time of ECG reading
    Descrição

    time of ECG

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    heart rate
    Descrição

    heart rate

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    bpm
    P-R interval
    Descrição

    P-R interval

    Tipo de dados

    float

    Unidades de medida
    • sec
    Alias
    UMLS CUI [1]
    C0429087
    sec
    QRS Interval
    Descrição

    QRS Interval

    Tipo de dados

    float

    Unidades de medida
    • sec
    Alias
    UMLS CUI [1]
    C0520880
    sec
    QTc interval
    Descrição

    QTc interval

    Tipo de dados

    float

    Unidades de medida
    • sec
    Alias
    UMLS CUI [1]
    C0855331
    sec
    Overall ECG results
    Descrição

    ECG results

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1274040
    If abnormal - clinically significant, describe
    Descrição

    Specify ECG abnormality

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C1521902
    Orthostatic blood pressure / Pulse
    Descrição

    Orthostatic blood pressure / Pulse

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C1095971
    UMLS CUI-3
    C0232117
    Screening date of visit
    Descrição

    Screening date of visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C1710477
    Heart Rate semi-supine
    Descrição

    Heart rate Semi-Supine

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    bpm
    Heart Rate standing
    Descrição

    Heart Rate standing

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C2029905
    bpm
    Systolic blood pressure semi-supine
    Descrição

    Systolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Diastolic blood pressure semi-supine
    Descrição

    Diastolic blood pressure semi-supine

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Systolic blood pressure standing
    Descrição

    Systolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Diastolic blood pressure standing
    Descrição

    Diastolic blood pressure standing

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C1303019
    mmHg
    Pregnancy test
    Descrição

    Pregnancy test

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test performed?
    Descrição

    pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0032976
    If yes, what type of pregnancy test was performed?
    Descrição

    pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Date of pregnancy test
    Descrição

    Date of pregnancy test

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Result
    Descrição

    Result of pregnancy test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0427777
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    Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    age and child-bearing potential contraception
    Item
    Men or women 30 to 85 years of age, inclusive, at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraception [i.e. Norplant System]), during the study and for at least one month prior to randomization and one month following completion of the study.
    boolean
    C0001779 (UMLS CUI [1,1])
    C1960468 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    idiopathic Parkinson's disease Hoehn&Yahr Stage
    Item
    Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
    boolean
    C0865475 (UMLS CUI [1,1])
    C3639483 (UMLS CUI [1,2])
    study subject participation status ropinirole or candidate for dopaminergic therapy
    Item
    Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0244821 (UMLS CUI [1,2])
    C3267134 (UMLS CUI [2])
    bmi
    Item
    Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
    boolean
    C1305855 (UMLS CUI [1])
    informed consent
    Item
    Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
    boolean
    C0021430 (UMLS CUI [1])
    exemption approved
    Item
    If any question is answered NO, was exemption approved by Medical Monitor?
    boolean
    C0585836 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Medical monitor name
    Item
    Approved by
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Date of approval
    Item
    Date
    date
    C2346844 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    physical examination abnormality
    Item
    Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
    boolean
    C0031809 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0035648 (UMLS CUI [2])
    psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy
    Item
    Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson s disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident [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 [5,1])
    C0027765 (UMLS CUI [5,2])
    C0007222 (UMLS CUI [6])
    C0006826 (UMLS CUI [7])
    laboratory abnormality 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
    C0438215 (UMLS CUI [1])
    C0522055 (UMLS CUI [2])
    Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody
    Item
    Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
    boolean
    C0019168 (UMLS CUI [1,1])
    C0166049 (UMLS CUI [1,2])
    C0019683 (UMLS CUI [2])
    alcohol breath test or blood test and/or urine drugs of abuse test at screening
    Item
    Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
    boolean
    C0202306 (UMLS CUI [1,1])
    C1710477 (UMLS CUI [1,2])
    C1167994 (UMLS CUI [1,3])
    C1710477 (UMLS CUI [1,4])
    C0451130 (UMLS CUI [2,1])
    C1710477 (UMLS CUI [2,2])
    syncope or orthostatic hypotension
    Item
    Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
    boolean
    C0020651 (UMLS CUI [1])
    C0039070 (UMLS CUI [2,1])
    C0262926 (UMLS CUI [2,2])
    sleep disorder or Epworth Sleep Score 39
    Item
    Significant sleep disorder or screening Epworth Sleep Score 39.
    boolean
    C0851578 (UMLS CUI [1,1])
    C2129304 (UMLS CUI [1,2])
    Abnormal diastolic arterial pressure or abnormal systolic arterial pressure
    Item
    Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
    boolean
    C0277888 (UMLS CUI [1])
    C0277883 (UMLS CUI [2])
    Treatment with L-Dopa
    Item
    Currently receiving any L-dopa dose or preparation.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    History of any dopaminergic treatments
    Item
    History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
    boolean
    C0013036 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    hormone replacement therapy or CYP1A2 inhibitors or inducers
    Item
    Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
    boolean
    C3850050 (UMLS CUI [1])
    C3850068 (UMLS CUI [2])
    C0282402 (UMLS CUI [3])
    Blood donation or significant blood loss
    Item
    Blood donation or significant blood loss less than 90 days before the present study.
    boolean
    C0005795 (UMLS CUI [1])
    C3163616 (UMLS CUI [2])
    personal history, or family history, of adverse reactions or hypersensitivity 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.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0244821 (UMLS CUI [1,2])
    C0241889 (UMLS CUI [1,3])
    C0559546 (UMLS CUI [1,4])
    C0244821 (UMLS CUI [1,5])
    C0241889 (UMLS CUI [1,6])
    C0020517 (UMLS CUI [2,1])
    C0244821 (UMLS CUI [2,2])
    C0332119 (UMLS CUI [2,3])
    C0559546 (UMLS CUI [3,1])
    C0244821 (UMLS CUI [3,2])
    C0332119 (UMLS CUI [3,3])
    Use of any investigational drug
    Item
    Use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing.
    boolean
    C0013230 (UMLS CUI [1])
    over-the-counter (OTC) medicine
    Item
    Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C2709201 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    drug dependence or abuse of alcohol
    Item
    Recent history, or suspicion, of drug dependence or abuse of alcohol.
    boolean
    C1510472 (UMLS CUI [1,1])
    C0085762 (UMLS CUI [1,2])
    drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour
    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
    C2347852 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1321605 (UMLS CUI [1,3])
    pregnant or breast-feeding
    Item
    Women who are pregnant or breast-feeding
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    exemption approved
    Item
    If any question is answered NO, was exemption approved by Medical Monitor?
    boolean
    C0585836 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Medical monitor name
    Item
    Approved by
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Date of approval
    Item
    Date
    date
    C2346844 (UMLS CUI [1])
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    integer
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male (1)
    CL Item
    Female (2)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Caucasian (1)
    CL Item
    Black (2)
    CL Item
    Asian (3)
    CL Item
    Hispanic (4)
    CL Item
    other (5)
    Other race specify
    Item
    Please specify other racial group.
    text
    C0034510 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Medical history
    C0262926 (UMLS CUI-1)
    Item
    Body system
    integer
    C1268086 (UMLS CUI [1,1])
    C0449913 (UMLS CUI [1,2])
    Body system
    Code List
    Body system
    CL Item
    General appearance and skin (1)
    CL Item
    Head, eyes, ears, nose, throat (2)
    CL Item
    Cardiovascular (3)
    CL Item
    Respiratory (4)
    CL Item
    Abdominal and gastrointestinal (5)
    CL Item
    Musculoskeletal (6)
    CL Item
    Neurological (7)
    CL Item
    Genitourinary (8)
    CL Item
    Hematopoietic and lymphatic (9)
    CL Item
    Endocrine and metabolic (10)
    CL Item
    other (11)
    Item
    Body system
    integer
    C0460002 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Body system abnormality
    Code List
    Body system
    CL Item
    normal (1)
    CL Item
    abnormal (2)
    Describe abnormality body system
    Item
    Describe abnormality
    text
    C0459424 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Item Group
    Surgical history: Parkinson's disease
    C0030567 (UMLS CUI-1)
    C0455610 (UMLS CUI-2)
    Surgical Procedures Parkinson's Disease
    Item
    Surgical Procedures related to Parkinson's Disease
    boolean
    C0030567 (UMLS CUI [1,1])
    C0455610 (UMLS CUI [1,2])
    Date of surgical procedure Parkinson's disease
    Item
    Date
    date
    C0543467 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0030567 (UMLS CUI [1,3])
    Surgical procedure Parkinson's disease
    Item
    Procedure
    text
    C0543467 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    Item Group
    Allergies
    C0020517 (UMLS CUI-1)
    Allergies
    Item
    Allergies
    boolean
    C0020517 (UMLS CUI [1])
    Allergen
    Item
    Allergen
    text
    C0002092 (UMLS CUI [1])
    Allergic reaction
    Item
    Reaction
    text
    C1527304 (UMLS CUI [1])
    Item Group
    Parkinson's disease history
    C0030567 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Date of Onset Parkinson's Disease
    Item
    Date of Onset of Symptoms of Parkinson's Disease
    date
    C0030567 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Item Group
    12-lead electrocardiogram report
    C0430456 (UMLS CUI-1)
    time of ECG
    Item
    Actual time of ECG reading
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    heart rate
    Item
    heart rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    P-R interval
    Item
    P-R interval
    float
    C0429087 (UMLS CUI [1])
    QRS Interval
    Item
    QRS Interval
    float
    C0520880 (UMLS CUI [1])
    QTc interval
    Item
    QTc interval
    float
    C0855331 (UMLS CUI [1])
    Item
    Overall ECG results
    integer
    C1623258 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    ECG results
    Code List
    Overall ECG results
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    Specify ECG abnormality
    Item
    If abnormal - clinically significant, describe
    text
    C0522055 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    Orthostatic blood pressure / Pulse
    C0518766 (UMLS CUI-1)
    C1095971 (UMLS CUI-2)
    C0232117 (UMLS CUI-3)
    Screening date of visit
    Item
    Screening date of visit
    date
    C1320303 (UMLS CUI [1,1])
    C1710477 (UMLS CUI [1,2])
    Heart rate Semi-Supine
    Item
    Heart Rate semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart Rate standing
    Item
    Heart Rate standing
    integer
    C2029905 (UMLS CUI [1])
    Systolic blood pressure semi-supine
    Item
    Systolic blood pressure semi-supine
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic blood pressure semi-supine
    Item
    Diastolic blood pressure semi-supine
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Systolic blood pressure standing
    Item
    Systolic blood pressure standing
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic blood pressure standing
    Item
    Diastolic blood pressure standing
    integer
    C1303019 (UMLS CUI [1])
    Item Group
    Pregnancy test
    C0032976 (UMLS CUI-1)
    Item
    Was a pregnancy test performed?
    integer
    C0032976 (UMLS CUI [1])
    pregnancy test
    Code List
    Was a pregnancy test performed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Item
    If yes, what type of pregnancy test was performed?
    integer
    C0032976 (UMLS CUI [1])
    pregnancy test
    Code List
    If yes, what type of pregnancy test was performed?
    CL Item
    Serum (1)
    CL Item
    Urine (2)
    Date of pregnancy test
    Item
    Date of pregnancy test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result
    integer
    C0427777 (UMLS CUI [1])
    Result of pregnancy test
    Code List
    Result
    CL Item
    positive (1)
    CL Item
    negative (2)
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