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ID

26417

Description

Study Part: Pre-dose Checklist Week 3 PK Visit (Visit 8). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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Versions (1)
  1. 10/17/17 10/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Pre-dose Checklist Week 3 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165

    English

    Pre-dose Checklist Week 3 PK Visit (Visit 8)

    1 forms  
    PREDOSE CHECKLIST
    Description

    PREDOSE CHECKLIST

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Description

    alcohol consumption

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    2. Has the patient tried to refrain from consuming xanthine-containing beverage and foods (coffee, tea, cola beverages, cocoa, chocolate), grapefruit-containing products, quinine-containing products and food containing CYP1A2-inducing constituents (broccoli, bussels sprouts, cabbage etc.) within 24 hours of the clinic visit?
    Description

    xanthine-containing beverage and foods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0043314
    UMLS CUI [1,2]
    C0016452
    3. Has the patient refrained from consuming poppy seed-containing food (e.g. poppy cake) for three days before the clinic visit?
    Description

    poppy seed-containing food

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0453264
    UMLS CUI [1,2]
    C0016452
    4. Has the patient maintained their normal smoking practice?
    Description

    smoking history

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519384
    5. Has the subject had at least 3 sequential days of dosing?
    Description

    dosage

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178602
    6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
    Description

    CYP1A2 inhibitors or inducers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1827504
    UMLS CUI [1,2]
    C1827490
    Comments:
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    Pre-dose Checklist Week 3 PK Visit (Visit 8)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    PREDOSE CHECKLIST
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    alcohol consumption
    Item
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1])
    xanthine-containing beverage and foods
    Item
    2. Has the patient tried to refrain from consuming xanthine-containing beverage and foods (coffee, tea, cola beverages, cocoa, chocolate), grapefruit-containing products, quinine-containing products and food containing CYP1A2-inducing constituents (broccoli, bussels sprouts, cabbage etc.) within 24 hours of the clinic visit?
    boolean
    C0043314 (UMLS CUI [1,1])
    C0016452 (UMLS CUI [1,2])
    poppy seed-containing food
    Item
    3. Has the patient refrained from consuming poppy seed-containing food (e.g. poppy cake) for three days before the clinic visit?
    boolean
    C0453264 (UMLS CUI [1,1])
    C0016452 (UMLS CUI [1,2])
    Item
    4. Has the patient maintained their normal smoking practice?
    text
    C1519384 (UMLS CUI [1])
    smoking history
    Code List
    4. Has the patient maintained their normal smoking practice?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    N/A (N/A)
    Item
    5. Has the subject had at least 3 sequential days of dosing?
    text
    C0178602 (UMLS CUI [1])
    smoking history
    Code List
    5. Has the subject had at least 3 sequential days of dosing?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    N/A (N/A)
    Item
    6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
    text
    C1827504 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    smoking history
    Code List
    6. If the patient is already taking a drug known to substantially inhibit CYP1A2 or induce CYP1A2, has the patient remained on stable doses of the agent from 7 days prior to dosing with study medication?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    N/A (N/A)
    Comments
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
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