0 Ratings
ID

21089

Description

Documentation Part: Treatment Phase Day 1 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 (4)
  1. 3/3/17 3/3/17 -
  2. 3/4/17 3/4/17 -
  3. 3/8/17 3/8/17 -
  4. 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 1 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    English

    Treatment Phase Day 1 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
    Urine drug screen
    Description

    Urine drug screen

    Alias
    UMLS CUI-1
    C0202274
    Date and time of sample taken
    Description

    Date and time of sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C0011008
    UMLS CUI [2]
    C0040223
    Amphetamines
    Description

    Amphetamines

    Data type

    text

    Alias
    UMLS CUI [1]
    C0002667
    Barbiturates
    Description

    Barbiturates

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004745
    Cannabis
    Description

    Cannabis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0936079
    Cocaine
    Description

    Cocaine

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009170
    Alcohol test
    Description

    Alcohol test

    Alias
    UMLS CUI-1
    C0868676
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0868676
    Results
    Description

    Results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0868676
    Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)
    Description

    Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)

    Alias
    UMLS CUI-1
    C0032976
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0032976
    Results
    Description

    Results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0032976
    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
    Randomisation number
    Description

    Randomisation number

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

    Record randomisation number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Date of randomisation
    Description

    Date of randomisation

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Time of randomisation
    Description

    Time of randomisation

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Invesatigational product
    Description

    Invesatigational product

    Alias
    UMLS CUI-1
    C3898691
    Planned timepoint
    Description

    Planned timepoint

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348792
    Date of dose
    Description

    Date of dose

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Time of dose
    Description

    Time of dose

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Treatment confirmation
    Description

    Treatment confirmation

    Alias
    UMLS CUI-1
    C0750484
    UMLS CUI-2
    C0087111
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Description

    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If No, record reason(s)
    Description

    If No, record reason(s)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0750484
    UMLS CUI [1,3]
    C0087111
    Ambulatory blood pressure monitoring
    Description

    Ambulatory blood pressure monitoring

    Alias
    UMLS CUI-1
    C0026426
    UMLS CUI-2
    C0439841
    Start date
    Description

    Start date

    Data type

    date

    Measurement units
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Day Month Year
    Start time
    Description

    Start time

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
    Stop time
    Description

    Stop time

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
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    Similar models

    Treatment Phase Day 1 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
    Urine drug screen
    C0202274 (UMLS CUI-1)
    Date and time of sample taken
    Item
    Date and time of sample taken
    datetime
    C0011008 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    Item
    Amphetamines
    text
    C0002667 (UMLS CUI [1])
    Amphetamines
    Code List
    Amphetamines
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Barbiturates
    text
    C0004745 (UMLS CUI [1])
    Barbiturates
    Code List
    Barbiturates
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Cannabis
    text
    C0936079 (UMLS CUI [1])
    Cannabis
    Code List
    Cannabis
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Cocaine
    text
    C0009170 (UMLS CUI [1])
    Cocaine
    Code List
    Cocaine
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item Group
    Alcohol test
    C0868676 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0868676 (UMLS CUI [1,2])
    Item
    Results
    text
    C0587081 (UMLS CUI [1,1])
    C0868676 (UMLS CUI [1,2])
    Results
    Code List
    Results
    CL Item
    positive (if positive, exclude subject from study) (1)
    CL Item
    negative (2)
    Item Group
    Pregnancy test (Complete for Female Subjects of Child-bearing Potential Only)
    C0032976 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Item
    Results
    text
    C0587081 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Results
    Code List
    Results
    CL Item
    positive (If positive, exclude subject from study) (1)
    CL Item
    negative (2)
    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 (1)
    CL Item
    Pre-dose 2 (2)
    CL Item
    Pre-dose 3 (3)
    CL Item
    Unscheduled (4)
    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
    Pre-dose 2 (2)
    CL Item
    Pre-dose 3 (3)
    CL Item
    Unscheduled (4)
    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
    Randomisation number
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Record randomisation number
    Item
    Record randomisation number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of randomisation
    Item
    Date of randomisation
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of randomisation
    Item
    Time of randomisation
    time
    C0034656 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Invesatigational product
    C3898691 (UMLS CUI-1)
    Planned timepoint
    Item
    Planned timepoint
    text
    C2348792 (UMLS CUI [1])
    Date of dose
    Item
    Date of dose
    date
    C0013227 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of dose
    Item
    Time of dose
    time
    C0013227 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Treatment confirmation
    C0750484 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Code List
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    If No, record reason(s)
    Item
    If No, record reason(s)
    text
    C0392360 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Item Group
    Ambulatory blood pressure monitoring
    C0026426 (UMLS CUI-1)
    C0439841 (UMLS CUI-2)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Stop time
    Item
    Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
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