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25992

Beschrijving

PART A - Period 2 - Day 2 - 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

Trefwoorden

Versies (1)
  1. 03-10-17 03-10-17 -
Houder van rechten

glaxoSmithKline

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3 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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    PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    Engels

    PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulieren  
    Orthostatic blood pressure / Pulse - Predose
    Beschrijving

    Orthostatic blood pressure / Pulse - Predose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C1095971
    UMLS CUI-3
    C0232117
    UMLS CUI-4
    C3812758
    Date of visit
    Beschrijving

    Date of visit

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C3812758
    Time
    Beschrijving

    Time vital signs

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Heart Rate semi-supine
    Beschrijving

    Heart rate Semi-Supine

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    bpm
    Heart Rate standing
    Beschrijving

    Heart Rate standing

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1,1]
    C2029905
    UMLS CUI [1,2]
    C3812758
    bpm
    Systolic blood pressure semi-supine
    Beschrijving

    Systolic blood pressure semi-supine

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure semi-supine
    Beschrijving

    Diastolic blood pressure semi-supine

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C3812758
    mmHg
    Systolic blood pressure standing
    Beschrijving

    Systolic blood pressure standing

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C3812758
    mmHg
    Diastolic blood pressure standing
    Beschrijving

    Diastolic blood pressure standing

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C1303019
    UMLS CUI [1,2]
    C3812758
    mmHg
    Concomitant medication
    Beschrijving

    Concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    Has the subject had any changes in medication since the last study visit?
    Beschrijving

    If 'Yes', please document on the Concomitant Medication Report Forms.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0580105
    Have the subject's smoking habits remained unchanged?
    Beschrijving

    tobacco use unchanged

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0442739
    Has the subject been reminded to comply with suggested dietary restrictions?
    Beschrijving

    dietary restrictions

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0425422
    UMLS CUI [1,2]
    C1321605
    Has the subject continued to refrain from alcohol consumption as instructed?
    Beschrijving

    alcohol consumption restricted

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    Adverse event
    Beschrijving

    Adverse event

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any Adverse Events since the last study contact?
    Beschrijving

    If 'Yes', please document on the Adverse Event Report Forms.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Patient diary
    Beschrijving

    Patient diary

    Alias
    UMLS CUI-1
    C3890583
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    Beschrijving

    Patient diary

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3890583
    Standard Breakfast
    Beschrijving

    Standard Breakfast

    Alias
    UMLS CUI-1
    C2698559
    Breakfast started
    Beschrijving

    Breakfast started

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0439659
    Breakfast ended
    Beschrijving

    Breakfast ended

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C2698559
    UMLS CUI [1,2]
    C0444930
    Did the subject complete the breakfast?
    Beschrijving

    Breakfast completed

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0814440
    UMLS CUI [1,2]
    C0205197
    If no, please comment:
    Beschrijving

    Breakfast not completed comment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0814440
    UMLS CUI [1,3]
    C0205197
    Pharmacokinetics
    Beschrijving

    Pharmacokinetics

    Alias
    UMLS CUI-1
    C0031327
    PK specimen drawn
    Beschrijving

    prior to dosing

    Datatype

    time

    Maateenheden
    • hh:mm
    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0807979
    hh:mm
    Study Drug Dosing
    Beschrijving

    Study Drug Dosing

    Alias
    UMLS CUI-1
    C0013175
    UMLS CUI-2
    C0678766
    Dosage given
    Beschrijving

    The subject will not be allowed to lie down or sleep for 4 hours after the morning dose.

    Datatype

    float

    Maateenheden
    • mg/day
    Alias
    UMLS CUI [1]
    C0678766
    mg/day
    Dosage
    Beschrijving

    Dosage

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C3854006
    Time of dosing
    Beschrijving

    Time of Dosing

    Datatype

    time

    Maateenheden
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    24hr:min
    Was study medication dispensed to the subject?
    Beschrijving

    Study medication dispensed

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3854006
    UMLS CUI [1,2]
    C0947323
    Witness 1
    Beschrijving

    Witness 1

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness 2
    Beschrijving

    Witness 2

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C0001555
    Witness date
    Beschrijving

    Witness date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C4263486
    UMLS CUI [1,2]
    C0011008
    Discharge
    Beschrijving

    Discharge

    Alias
    UMLS CUI-1
    C0030685
    Time of discharge from study site
    Beschrijving

    Discharge Time

    Datatype

    time

    Alias
    UMLS CUI [1]
    C3864299
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    Similar models

    PART A - Period 2 - Day 2 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Orthostatic blood pressure / Pulse - Predose
    C0518766 (UMLS CUI-1)
    C1095971 (UMLS CUI-2)
    C0232117 (UMLS CUI-3)
    C3812758 (UMLS CUI-4)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Time vital signs
    Item
    Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Heart rate Semi-Supine
    Item
    Heart Rate semi-supine
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Heart Rate standing
    Item
    Heart Rate standing
    integer
    C2029905 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Systolic blood pressure semi-supine
    Item
    Systolic blood pressure semi-supine
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure semi-supine
    Item
    Diastolic blood pressure semi-supine
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Systolic blood pressure standing
    Item
    Systolic blood pressure standing
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C3812758 (UMLS CUI [1,3])
    Diastolic blood pressure standing
    Item
    Diastolic blood pressure standing
    integer
    C1303019 (UMLS CUI [1,1])
    C3812758 (UMLS CUI [1,2])
    Item Group
    Concomitant medication
    C2347852 (UMLS CUI-1)
    Item
    Has the subject had any changes in medication since the last study visit?
    integer
    C0580105 (UMLS CUI [1])
    changes in medication
    Code List
    Has the subject had any changes in medication since the last study visit?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Have the subject's smoking habits remained unchanged?
    integer
    C0543414 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    tobacco use unchanged
    Code List
    Have the subject's smoking habits remained unchanged?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Has the subject been reminded to comply with suggested dietary restrictions?
    integer
    C0425422 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    dietary restrictions
    Code List
    Has the subject been reminded to comply with suggested dietary restrictions?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Has the subject continued to refrain from alcohol consumption as instructed?
    integer
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    alcohol consumption restricted
    Code List
    Has the subject continued to refrain from alcohol consumption as instructed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Adverse event
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any Adverse Events since the last study contact?
    integer
    C0877248 (UMLS CUI [1])
    adverse event
    Code List
    Has the subject experienced any Adverse Events since the last study contact?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Patient diary
    C3890583 (UMLS CUI-1)
    Patient diary
    Item
    Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
    text
    C3890583 (UMLS CUI [1])
    Item Group
    Standard Breakfast
    C2698559 (UMLS CUI-1)
    Breakfast started
    Item
    Breakfast started
    time
    C2698559 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    Breakfast ended
    Item
    Breakfast ended
    time
    C2698559 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Breakfast completed
    Item
    Did the subject complete the breakfast?
    boolean
    C0814440 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Breakfast not completed comment
    Item
    If no, please comment:
    text
    C0947611 (UMLS CUI [1,1])
    C0814440 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics
    C0031327 (UMLS CUI-1)
    Pharmacokinetics
    Item
    PK specimen drawn
    time
    C0031327 (UMLS CUI [1,1])
    C0807979 (UMLS CUI [1,2])
    Item Group
    Study Drug Dosing
    C0013175 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    Dosage given
    Item
    Dosage given
    float
    C0678766 (UMLS CUI [1])
    Item
    Dosage
    integer
    C0178602 (UMLS CUI [1,1])
    C3854006 (UMLS CUI [1,2])
    Dosage
    Code List
    Dosage
    CL Item
    CR (1)
    CL Item
    IR (2)
    Time of Dosing
    Item
    Time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Was study medication dispensed to the subject?
    integer
    C3854006 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Study medication dispensed
    Code List
    Was study medication dispensed to the subject?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    Witness 1
    Item
    Witness 1
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness 2
    Item
    Witness 2
    text
    C0682356 (UMLS CUI [1,1])
    C0001555 (UMLS CUI [1,2])
    Witness date
    Item
    Witness date
    date
    C4263486 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Discharge
    C0030685 (UMLS CUI-1)
    Discharge Time
    Item
    Time of discharge from study site
    time
    C3864299 (UMLS CUI [1])
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