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ID

25532

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Keywords

Versions (2)
  1. 9/5/17 9/5/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 5, 2017

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License

Creative Commons BY-NC 3.0
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    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    English

    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Focus Panel ID
    Description

    focus panel

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Patient No
    Description

    patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Baseline Signs and Symptoms
    Description

    Baseline Signs and Symptoms

    Alias
    UMLS CUI-1
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    Did the subject experience any symptoms prior to the first study drug administration?
    Description

    If YES, indicate below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [2,1]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2,2]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    Events
    Description

    Events

    Alias
    UMLS CUI-1
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    Diagnosis or signs/symptoms
    Description

    diagnosis or signs/symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [2]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    Date and time of onset
    Description

    24-hour clock

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1717740 (undefined)
    Maximum Intensity
    Description

    maximum intensity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518690 (Symptom intensity)
    Event course
    Description

    If INTERMITTENT, record the number of episodes.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0750729 (Course)
    SNOMED
    288524001
    Outcome
    Description

    outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1547647 (Patient Outcome)
    Date and Time of Resolution
    Description

    date and time of resolution

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1264639 (Date/Time)
    SNOMED
    118575009
    UMLS CUI [1,2]
    C2699488 (Resolution)
    Withdrawal
    Description

    Did the subject withdraw from study as a result of this symptom?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Relationship to study procedere(s)
    Description

    relationship to study

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    Corrective therapy
    Description

    if YES please record on the "prior medication" page

    Data type

    text

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
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    Similar models

    baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    focus panel
    Item
    Focus Panel ID
    integer
    C3846158 (UMLS CUI [1])
    patient number
    Item
    Patient No
    integer
    C1830427 (UMLS CUI [1])
    Item Group
    Baseline Signs and Symptoms
    C0037088 (UMLS CUI-1)
    Item
    Did the subject experience any symptoms prior to the first study drug administration?
    text
    C1457887 (UMLS CUI [1])
    C0332152 (UMLS CUI [2,1])
    C3469597 (UMLS CUI [2,2])
    symptoms before first dose of study drug
    Code List
    Did the subject experience any symptoms prior to the first study drug administration?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    Events
    C0441471 (UMLS CUI-1)
    diagnosis or signs/symptoms
    Item
    Diagnosis or signs/symptoms
    text
    C0011900 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    date and time
    Item
    Date and time of onset
    datetime
    C1717740 (UMLS CUI [1])
    Item
    Maximum Intensity
    integer
    C0518690 (UMLS CUI [1])
    maximum intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Event course
    text
    C0750729 (UMLS CUI [1])
    event course
    Code List
    Event course
    CL Item
    Intermittent (I)
    CL Item
    Constant (C)
    Item
    Outcome
    text
    C1547647 (UMLS CUI [1])
    outcome
    Code List
    Outcome
    CL Item
    Resolved (R)
    CL Item
    Ongoing (O)
    date and time of resolution
    Item
    Date and Time of Resolution
    datetime
    C1264639 (UMLS CUI [1,1])
    C2699488 (UMLS CUI [1,2])
    Item
    Withdrawal
    text
    C0422727 (UMLS CUI [1])
    withdrawal
    Code List
    Withdrawal
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Relationship to study procedere(s)
    integer
    C0013227 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    relationship to study
    Code List
    Relationship to study procedere(s)
    CL Item
    Related (1)
    CL Item
    Possibly related (2)
    CL Item
    Probably unrelated (3)
    CL Item
    Unrelated (4)
    Item
    Corrective therapy
    text
    C0087111 (UMLS CUI [1])
    therapy
    Code List
    Corrective therapy
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Back to the top of the page 

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