0 Ratings
ID

36118

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 Form D. It can be filled in for the end of study.

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Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 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

    Form D

    1 forms  
    1. StudyEvent: ODM
      1. Form D
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    GSK Receipt Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Form D
    Description

    Form D

    Alias
    UMLS CUI-1
    C0011065
    Certified Cause of Death
    Description

    Cause of Death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465
    Date of Death
    Description

    day month year Complete Adverse Event From.

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Was an autopsy done?
    Description

    Autopsy

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0884358
    If an autopsy was done, please summarize findings (include diagnosis)
    Description

    Autopsy findings

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [2,1]
    C0004398
    UMLS CUI [2,2]
    C0011900
    Investigator's Signature
    Description

    Investigator's Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Form D

    1 forms
    1. StudyEvent: ODM
      1. Form D
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Form D
    C0011065 (UMLS CUI-1)
    Cause of Death
    Item
    Certified Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Date of Death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Item
    Was an autopsy done?
    text
    C0004398 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Autopsy
    Code List
    Was an autopsy done?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Autopsy findings
    Item
    If an autopsy was done, please summarize findings (include diagnosis)
    text
    C0004398 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C0004398 (UMLS CUI [2,1])
    C0011900 (UMLS CUI [2,2])
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Back to the top of the page 

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