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35978

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Significant Medical/Surgical History and Physical examination. Both has to be filled in for screening. Physical examination has to be filled in for Follow-up too.

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Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

GlaxoSmithKline

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April 8, 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Significant Medical/Surgical History, Physical examination

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID:
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit type
    Description

    Fill in "Physical examination" for both screening and follow-up. "Medical hitory" is only for sceening mandatory.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Significant Medical/Surgical History
    Description

    Significant Medical/Surgical History

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
    Description

    If Yes, list below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0489540
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    GSK Use
    Description

    Investigator Use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0457083
    Year of first diagnosis
    Description

    Month/Year

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2316983
    Past
    Description

    Diagnosis from past

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0455458
    Ongoing
    Description

    Ongoing disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0012634
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date of Assessment
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Any findings?
    Description

    "Physical Examination should be performed and any relevant findings must be described on the Medical History form (for findings of the past), or on the Baseline Sign/Symptom form (for findings presently occurring, events existing prior to drug administration). IMPORTANT: these findings, or events, must have a complete starting date that is at, or before, the date of the assessment (so that these are clearly pre-treatment findings, or events)." If any clinically significant abnormalities are present, DO NOT INCLUDE the subject.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0243095
    If there are any findings, please speficy the region
    Description

    Findings, specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C2348235
    If other findings, please specify
    Description

    Other findings

    Data type

    text

    Alias
    UMLS CUI [1]
    C1335151
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    Similar models

    Significant Medical/Surgical History, Physical examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID:
    text
    C3846158 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    Follow-up (2)
    Item Group
    Significant Medical/Surgical History
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    Item
    Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
    text
    C0262926 (UMLS CUI [1])
    C0489540 (UMLS CUI [2])
    Significant Medical/Surgical History
    Code List
    Is the subject suffering from or has he/she ever suffered from any SIGNIFICANT medical or surgical condition?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Investigator Use
    Item
    GSK Use
    text
    C0008961 (UMLS CUI [1,1])
    C0457083 (UMLS CUI [1,2])
    Year of first diagnosis
    Item
    Year of first diagnosis
    partialDate
    C2316983 (UMLS CUI [1])
    Diagnosis from past
    Item
    Past
    boolean
    C0455458 (UMLS CUI [1])
    Ongoing disease
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Any findings?
    text
    C0031809 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Findings
    Code List
    Any findings?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    If there are any findings, please speficy the region
    integer
    C0243095 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Findings, specification
    Code List
    If there are any findings, please speficy the region
    CL Item
    Head, ears, eyes, nose, throat (1)
    CL Item
    Cardiovascular (2)
    CL Item
    Respiratory (3)
    CL Item
    Lymph nodes (major lymph glands only) (4)
    CL Item
    Abdominal (5)
    CL Item
    Musculo-skeletal (6)
    CL Item
    Neurologic (7)
    CL Item
    Skin (8)
    CL Item
    Other (9)
    Other findings
    Item
    If other findings, please specify
    text
    C1335151 (UMLS CUI [1])
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