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ID

25740

Description

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Screening 0 form.

Keywords

Versions (1)
  1. 17/9/17 17/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

17 de septiembre de 2017

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Creative Commons BY-NC 3.0
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    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

    English

    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

    1 forms  
    DIARY INFORMATION
    Description

    DIARY INFORMATION

    Alias
    UMLS CUI-1
    C3890583
    Date of diary day 1
    Description

    Date of diary day 1

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0011008
    Total time asleep
    Description

    Total time asleep

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0037313
    Total awake time ’Off’
    Description

    awake time off

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time ’On’
    Description

    awake time On

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time "On" with troublesome dyskinesias
    Description

    awake time dyskinesias

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    UMLS CUI [1,3]
    C0013384
    Date of diary day 2
    Description

    Date of diary day 2

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0011008
    Total time asleep
    Description

    Total time asleep

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0037313
    Total awake time ’Off’
    Description

    awake time Off

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time ’On’
    Description

    awake time On

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    Total awake time "On" with troublesome dyskinesias
    Description

    awake time dyskinesias

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0234422
    UMLS CUI [1,3]
    C0013384
    General Information
    Description

    General Information

    Alias
    UMLS CUI-1
    C1508263
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    SUBJECT CONTINUATION
    Description

    SUBJECT CONTINUATION

    Alias
    UMLS CUI-1
    C0805733
    If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
    Description

    Subject continuation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0805733
    ADVERSE EVENTS PROMPT
    Description

    ADVERSE EVENTS PROMPT

    Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
    Description

    Adverse Events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    CONCOMITANT MEDICATION PROMPT
    Description

    CONCOMITANT MEDICATION PROMPT

    Alias
    UMLS CUI-1
    C2347852
    Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
    Description

    Concomitant Medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    L-DOPA MEDICATION CHANGES
    Description

    L-DOPA MEDICATION CHANGES

    Alias
    UMLS CUI-1
    C0023570
    UMLS CUI-2
    C0023570
    Has there been any change in dose or frequency of L-Dopa medication since the last visit?
    Description

    change L-Dopa medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    If Yes, tick the primary reason for change:
    Description

    reason for change

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    UMLS CUI [1,3]
    C0392360
    Other, specify
    Description

    reason for change

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0023570
    UMLS CUI [1,3]
    C0392360
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Blood Pressure Systolic
    Description

    Semi-Supine

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure Diastolic
    Description

    Semi-Supine

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Description

    Semi-Supine

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Blood Pressure Systolic
    Description

    Standing

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure Diastolic
    Description

    Standing

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Description

    Standing

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    CLINICAL GLOBAL IMPRESSION
    Description

    CLINICAL GLOBAL IMPRESSION

    Alias
    UMLS CUI-1
    C3639708
    CLINICAL GLOBAL IMPRESSION
    Description

    CLINICAL GLOBAL IMPRESSION

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3639708
    UNIFIED PARKINSONS DISEASE RATING SCALE
    Description

    UNIFIED PARKINSONS DISEASE RATING SCALE

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0030567
    UNIFIED PARKINSONS DISEASE RATING SCALE
    Description

    UNIFIED PARKINSONS DISEASE RATING SCALE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0030567
    PARKINSON’S DISEASE SLEEP SCALE
    Description

    PARKINSON’S DISEASE SLEEP SCALE

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0030567
    UMLS CUI-3
    C0037313
    PARKINSON’S DISEASE SLEEP SCALE
    Description

    PARKINSON’S DISEASE SLEEP SCALE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0030567
    UMLS CUI [1,3]
    C0037313
    BECK DEPRESSION INVENTORY
    Description

    BECK DEPRESSION INVENTORY

    Alias
    UMLS CUI-1
    C0451022
    BECK DEPRESSION INVENTORY
    Description

    BECK DEPRESSION INVENTORY

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0451022
    EPWORTH SLEEPINESS SCALE
    Description

    EPWORTH SLEEPINESS SCALE

    Alias
    UMLS CUI-1
    C3541276
    EPWORTH SLEEPINESS SCALE
    Description

    EPWORTH SLEEPINESS SCALE

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3541276
    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
    Description

    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0030567
    UMLS CUI-3
    C0034380
    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
    Description

    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0030567
    UMLS CUI [1,3]
    C0034380
    ELIGIBILITY QUESTION
    Description

    ELIGIBILITY QUESTION

    Alias
    UMLS CUI-1
    C1516637
    Did the subject meet all the entry criteria?
    Description

    Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    INCLUSION CRITERIA
    Description

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693
    A minimum of 3 hours awake “time–off” for each diary day recorded during the Placebo Run-In Period.
    Description

    awake time–off

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1718390
    EXCLUSION CRITERIA
    Description

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251
    Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
    Description

    abnormality

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0010340
    UMLS CUI [1,3]
    C0031809
    UMLS CUI [1,4]
    C0013798
    INVESTIGATIONAL PRODUCT
    Description

    INVESTIGATIONAL PRODUCT

    Alias
    UMLS CUI-1
    C0304229
    Blinded Dose Level
    Description

    Blinded Dose Level

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0304229
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0304229
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0304229
    Investigational product Container Number
    Description

    Investigational product Container Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    COMPLIANCE
    Description

    COMPLIANCE

    Alias
    UMLS CUI-1
    C1321605
    Total number of Tablets Dispensed
    Description

    Total number of Tablets Dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Total number of Tablets Returned
    Description

    Total number of Tablets Returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0039225
    Has the subject missed investigational product for more than 3 consecutive days?
    Description

    Has the subject missed investigational product for more than 3 consecutive days?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0304229
    DISPENSING
    Description

    DISPENSING

    Alias
    UMLS CUI-1
    C0947323
    Record dispensing information in the Investigational Product and Compliance sections at the next visit.
    Description

    Dispense investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0947323
    UMLS CUI [1,2]
    C0013230
    RANDOMISATION NUMBER
    Description

    RANDOMISATION NUMBER

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0237753
    Record randomisation number.
    Description

    Randomisation Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    DIARY CARD
    Description

    DIARY CARD

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C3812666
    UMLS CUI-3
    C1457887
    Issue the subject with Week 1 Diary Card
    Description

    Diary Card

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C3812666
    UMLS CUI [1,3]
    C1457887
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    GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    DIARY INFORMATION
    C3890583 (UMLS CUI-1)
    Date of diary day 1
    Item
    Date of diary day 1
    date
    C3890583 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Total time asleep
    Item
    Total time asleep
    time
    C0040223 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    awake time off
    Item
    Total awake time ’Off’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time On
    Item
    Total awake time ’On’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time dyskinesias
    Item
    Total awake time "On" with troublesome dyskinesias
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    C0013384 (UMLS CUI [1,3])
    Date of diary day 2
    Item
    Date of diary day 2
    date
    C3890583 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Total time asleep
    Item
    Total time asleep
    time
    C0040223 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    awake time Off
    Item
    Total awake time ’Off’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time On
    Item
    Total awake time ’On’
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    awake time dyskinesias
    Item
    Total awake time "On" with troublesome dyskinesias
    time
    C0040223 (UMLS CUI [1,1])
    C0234422 (UMLS CUI [1,2])
    C0013384 (UMLS CUI [1,3])
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    SUBJECT CONTINUATION
    C0805733 (UMLS CUI-1)
    Subject continuation
    Item
    If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
    boolean
    C0805733 (UMLS CUI [1])
    Item Group
    ADVERSE EVENTS PROMPT
    Adverse Events
    Item
    Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    CONCOMITANT MEDICATION PROMPT
    C2347852 (UMLS CUI-1)
    Concomitant Medication
    Item
    Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    L-DOPA MEDICATION CHANGES
    C0023570 (UMLS CUI-1)
    C0023570 (UMLS CUI-2)
    change L-Dopa medication
    Item
    Has there been any change in dose or frequency of L-Dopa medication since the last visit?
    boolean
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    Item
    If Yes, tick the primary reason for change:
    integer
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    reason for change
    Code List
    If Yes, tick the primary reason for change:
    CL Item
    Reduction required by protocol (starting at dose level 4)  (1)
    CL Item
    Unacceptable dopaminergic side-effect (Record in the Adverse Events section)  (2)
    CL Item
    Loss of efficacy  (3)
    CL Item
    Other, specify (4)
    reason for change
    Item
    Other, specify
    text
    C0023570 (UMLS CUI [1,1])
    C0023570 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    CLINICAL GLOBAL IMPRESSION
    C3639708 (UMLS CUI-1)
    CLINICAL GLOBAL IMPRESSION
    Item
    CLINICAL GLOBAL IMPRESSION
    boolean
    C3639708 (UMLS CUI [1])
    Item Group
    UNIFIED PARKINSONS DISEASE RATING SCALE
    C0030567 (UMLS CUI-1)
    C0030567 (UMLS CUI-2)
    UNIFIED PARKINSONS DISEASE RATING SCALE
    Item
    UNIFIED PARKINSONS DISEASE RATING SCALE
    boolean
    C0030567 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    Item Group
    PARKINSON’S DISEASE SLEEP SCALE
    C0030567 (UMLS CUI-1)
    C0030567 (UMLS CUI-2)
    C0037313 (UMLS CUI-3)
    PARKINSON’S DISEASE SLEEP SCALE
    Item
    PARKINSON’S DISEASE SLEEP SCALE
    boolean
    C0030567 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    C0037313 (UMLS CUI [1,3])
    Item Group
    BECK DEPRESSION INVENTORY
    C0451022 (UMLS CUI-1)
    BECK DEPRESSION INVENTORY
    Item
    BECK DEPRESSION INVENTORY
    boolean
    C0451022 (UMLS CUI [1])
    Item Group
    EPWORTH SLEEPINESS SCALE
    C3541276 (UMLS CUI-1)
    EPWORTH SLEEPINESS SCALE
    Item
    EPWORTH SLEEPINESS SCALE
    boolean
    C3541276 (UMLS CUI [1])
    Item Group
    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
    C0030567 (UMLS CUI-1)
    C0030567 (UMLS CUI-2)
    C0034380 (UMLS CUI-3)
    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
    Item
    PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE
    boolean
    C0030567 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    C0034380 (UMLS CUI [1,3])
    Item Group
    ELIGIBILITY QUESTION
    C1516637 (UMLS CUI-1)
    entry criteria
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    INCLUSION CRITERIA
    C1512693 (UMLS CUI-1)
    awake time–off
    Item
    A minimum of 3 hours awake “time–off” for each diary day recorded during the Placebo Run-In Period.
    boolean
    C1718390 (UMLS CUI [1])
    Item Group
    EXCLUSION CRITERIA
    C0680251 (UMLS CUI-1)
    abnormality
    Item
    Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
    boolean
    C1704258 (UMLS CUI [1,1])
    C0010340 (UMLS CUI [1,2])
    C0031809 (UMLS CUI [1,3])
    C0013798 (UMLS CUI [1,4])
    Item Group
    INVESTIGATIONAL PRODUCT
    C0304229 (UMLS CUI-1)
    Blinded Dose Level
    Item
    Blinded Dose Level
    integer
    C0178602 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Investigational product Container Number
    Item
    Investigational product Container Number
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    COMPLIANCE
    C1321605 (UMLS CUI-1)
    Total number of Tablets Dispensed
    Item
    Total number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Total number of Tablets Returned
    Item
    Total number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Has the subject missed investigational product for more than 3 consecutive days?
    Item
    Has the subject missed investigational product for more than 3 consecutive days?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item Group
    DISPENSING
    C0947323 (UMLS CUI-1)
    Dispense investigational product
    Item
    Record dispensing information in the Investigational Product and Compliance sections at the next visit.
    boolean
    C0947323 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Item Group
    RANDOMISATION NUMBER
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Randomisation Number
    Item
    Record randomisation number.
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    DIARY CARD
    C3890583 (UMLS CUI-1)
    C3812666 (UMLS CUI-2)
    C1457887 (UMLS CUI-3)
    Diary Card
    Item
    Issue the subject with Week 1 Diary Card
    boolean
    C3890583 (UMLS CUI [1,1])
    C3812666 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
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