0 Evaluaciones
ID

36117

Descripción

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 Comments and Missing Data form. It can be filled in for the end of study.

Palabras clave

Versiones (1)
  1. 15/4/19 15/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de abril de 2019

DOI

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Licencia

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

    Inglés

    Comments, Missing Data

    1 formularios  
    1. StudyEvent: ODM
      1. Comments, Missing Data
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    GSK Receipt Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Comments
    Descripción

    Comments

    Alias
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    Visit type
    Descripción

    Tick for the itemgroup "Comments"

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Department
    Descripción

    Department

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1704729 (Department)
    Number
    Descripción

    Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Signature
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Missing Data
    Descripción

    Missing Data

    Alias
    UMLS CUI-1
    C1705492 (Missing)
    LOINC
    LA14698-7
    UMLS CUI-2
    C1511726 (Data)
    Form
    Descripción

    Form

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0348078 (Qualitative form)
    SNOMED
    246176004
    Visit
    Descripción

    Visit

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Missing Data Point
    Descripción

    Missing Data Point

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1705492 (Missing)
    LOINC
    LA14698-7
    UMLS CUI [1,2]
    C1511726 (Data)
    Reason
    Descripción

    Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
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    Comments, Missing Data

    1 formularios
    1. StudyEvent: ODM
      1. Comments, Missing Data
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Date
    Item
    GSK Receipt Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Comments
    C0947611 (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
    Session 1 day 1 (2)
    CL Item
    Session 1 day 2 (3)
    CL Item
    Session 2 day 1  (4)
    CL Item
    Session 2 day 2 (5)
    CL Item
    Session 3 day 1 (6)
    CL Item
    Session 3 day 2 (7)
    CL Item
    Session 4 day 1 (8)
    CL Item
    Session 4 day 2 (9)
    CL Item
    Session 5 day 1 (10)
    CL Item
    Session 5 day 2 (11)
    CL Item
    Follow-up (12)
    Department
    Item
    Department
    text
    C1704729 (UMLS CUI [1])
    Number
    Item
    Number
    integer
    C0237753 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Item Group
    Missing Data
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Form
    Item
    Form
    text
    C0348078 (UMLS CUI [1])
    Item
    Visit
    integer
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Visit
    CL Item
    Screening (1)
    CL Item
    Session 1 day 1 (2)
    CL Item
    Session 1 day 2 (3)
    CL Item
    Session 2 day 1  (4)
    CL Item
    Session 2 day 2 (5)
    CL Item
    Session 3 day 1 (6)
    CL Item
    Session 3 day 2 (7)
    CL Item
    Session 4 day 1 (8)
    CL Item
    Session 4 day 2 (9)
    CL Item
    Session 5 day 1 (10)
    CL Item
    Session 5 day 2 (11)
    CL Item
    Follow-up (12)
    Missing Data Point
    Item
    Missing Data Point
    text
    C1705492 (UMLS CUI [1,1])
    C1511726 (UMLS CUI [1,2])
    Reason
    Item
    Reason
    text
    C0566251 (UMLS CUI [1])
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