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ID

36028

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 Pregnancy Information and Study Conclusion form. It has to be filled in for follow-up.

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Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

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April 9, 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

    Pregnancy Information, Study Conclusion

    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
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Description

    (mark one box below) If 'Yes' record details on Pregnancy Notification Form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3828490
    Did the female partner of a male patient become pregnant during the study?
    Description

    (mark one box below) If 'Yes' record details on Pregnancy Notification Form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0919624
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008972
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did the subject complete the study as planned?
    Description

    Subject completed study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2983670
    UMLS CUI [1,2]
    C2986196
    If subject did not complete the study, please mark the one most appropriate category
    Description

    IF you tick AE, please complete AE form.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3827242
    If other reason, please specify
    Description

    Other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    Comments on reason for withdrawal
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Date of Withdrawal
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0011008
    Time of Withdrawal
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0040223
    Date of Final Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    Time of Final Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0946444
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    Similar models

    Pregnancy Information, Study Conclusion

    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 Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Pregnant during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Not applicable (not of childbearing potential or male) (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Did the female partner of a male patient become pregnant during the study?
    text
    C0919624 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    undefined item
    Code List
    Did the female partner of a male patient become pregnant during the study?
    CL Item
    Not applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Did the subject complete the study as planned?
    text
    C2983670 (UMLS CUI [1,1])
    C2986196 (UMLS CUI [1,2])
    Subject completed study
    Code List
    Did the subject complete the study as planned?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If subject did not complete the study, please mark the one most appropriate category
    integer
    C3827242 (UMLS CUI [1])
    undefined item
    Code List
    If subject did not complete the study, please mark the one most appropriate category
    CL Item
    Adverse experience  (1)
    CL Item
    Protocol deviation (including non-compliance) (2)
    CL Item
    Lost to follow-up (3)
    CL Item
    Other (4)
    Other reason
    Item
    If other reason, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Comments
    Item
    Comments on reason for withdrawal
    text
    C0947611 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Date of Withdrawal
    Item
    Date of Withdrawal
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Withdrawal
    Item
    Time of Withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Date of Final Dose
    Item
    Date of Final Dose
    date
    C1762893 (UMLS CUI [1])
    Time of Final Dose
    Item
    Time of Final Dose
    time
    C0946444 (UMLS CUI [1])
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