0 Ratings
ID

21091

Description

Documentation Part: Treatment Phase Day 12-14 (PK Assessment Day) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Keywords

Versions (3)
  1. 3/4/17 3/4/17 -
  2. 3/8/17 3/8/17 -
  3. 4/10/17 4/10/17 -
Uploaded on

April 10, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Treatment Phase Day 12-14 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    English

    Treatment Phase Day 12-14 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 forms  
    Subject information
    Description

    Subject information

    Alias
    UMLS CUI-1
    C2707520
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit date
    Description

    Visit date

    Alias
    UMLS CUI-1
    C1320303
    Visit date
    Description

    Visit date

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1]
    C1320303
    Day Month Year
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    Date

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Planned Relative Time
    Description

    Planned Relative Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    Planned Absolute time
    Description

    Planned Absolute time

    Data type

    integer

    Measurement units
    • min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1552097
    min
    Actual time
    Description

    Actual time

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0428883
    mmHg
    Subject position
    Description

    Subject position

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    beats/min
    12-Lead-ECG
    Description

    12-Lead-ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Description

    Start date of ECG

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0013798
    Day Month Year
    Planned Relative Time
    Description

    Planned Relative Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    Start Time of ECG
    Description

    Start Time of ECG

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0013798
    Hr : Min
    Ventricular Rate
    Description

    Ventricular Rate

    Data type

    integer

    Measurement units
    • Beats/min
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    Beats/min
    PR Interval
    Description

    PR Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Description

    QRS Duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Invertal
    Description

    QTc Invertal

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0860814
    msec
    Result of the ECG
    Description

    Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Pharmacokinetics - Blood
    Description

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Description

    Time Relative to Dosing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0439564
    Date Sample Taken
    Description

    Date Sample Taken

    Data type

    date

    Measurement units
    • Day Month YearMonth Year
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0200345
    Day Month YearMonth Year
    Actual time
    Description

    Actual time

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C0200345
    Hr : Min
    Sample taken
    Description

    Sample taken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C1277698
    Sample Number
    Description

    Sample Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C1299222
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    Similar models

    Treatment Phase Day 12-14 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Subject information
    C2707520 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Visit date
    C1320303 (UMLS CUI-1)
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    4 hrs post-dose (2)
    CL Item
    6 hrs post-dose (3)
    CL Item
    12 hrs post-dose (4)
    CL Item
    24 hrs post-dose (5)
    CL Item
    Unscheduled (6)
    Planned Absolute time
    Item
    Planned Absolute time
    integer
    C0518766 (UMLS CUI [1,1])
    C1552097 (UMLS CUI [1,2])
    Actual time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    Item
    Subject position
    text
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Subject position
    Code List
    Subject position
    CL Item
    Supine (1)
    CL Item
    Standing (3)
    Heart Rate
    Item
    Heart Rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    12-Lead-ECG
    C0430456 (UMLS CUI-1)
    Start date of ECG
    Item
    Start date of ECG
    date
    C0808070 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose 1 (1)
    CL Item
    Unscheduled (2)
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C1301880 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    QRS Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    QTc Invertal
    Item
    QTc Invertal
    integer
    C0430456 (UMLS CUI [1,1])
    C0860814 (UMLS CUI [1,2])
    Result of the ECG
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Item Group
    Pharmacokinetics - Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    text
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    1 hr post-dose (2)
    CL Item
    2 hrs post-dose (3)
    CL Item
    4 hrs post-dose (4)
    CL Item
    6 hrs post-dose (5)
    CL Item
    8 hrs post-dose (6)
    CL Item
    10 hrs post-dose (7)
    CL Item
    12 hrs post-dose (8)
    CL Item
    14 hrs post-dose (9)
    CL Item
    16 hrs post-dose (10)
    CL Item
    20 hrs post-dose (11)
    CL Item
    24 hrs post-dose (12)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0200345 (UMLS CUI [1,4])
    Actual time
    Item
    Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0200345 (UMLS CUI [1,4])
    Item
    Sample taken
    text
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C1277698 (UMLS CUI [1,3])
    Sample taken
    Code List
    Sample taken
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Sample Number
    text
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C1299222 (UMLS CUI [1,3])
    Sample Number
    Code List
    Sample Number
    CL Item
    101 (1)
    CL Item
    102 (2)
    CL Item
    103 (3)
    CL Item
    104 (4)
    CL Item
    105 (5)
    CL Item
    106 (6)
    CL Item
    107 (7)
    CL Item
    108 (8)
    CL Item
    109 (9)
    CL Item
    110 (10)
    CL Item
    111 (11)
    CL Item
    112 (12)
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