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ID

27536

Description

Study Part: Study Conclusion Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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Versions (1)
  1. 11/19/17 11/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Study Conclusion Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165

    English

    Study Conclusion Follow- Up (Visit 10)

    1 forms  
    STUDY CONCLUSION
    Description

    STUDY CONCLUSION

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Did the subject complete the study as planned?
    Description

    Study Conclusion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707478
    UMLS CUI [1,2]
    C0008972
    If ’NO’, mark the one most appropriate category
    Description

    Study Conclusion

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1707478
    UMLS CUI [1,2]
    C0008972
    Other, Please specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394
    Comments on reason for withdrawal:
    Description

    Comment reason for withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C0008976
    Date of Withdrawal:
    Description

    Date of Withdrawal

    Data type

    date

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

    Time of Withdrawal

    Data type

    time

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

    Date of Final Dose

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Time of Final Dose:
    Description

    Time of Final Dose

    Data type

    time

    Alias
    UMLS CUI [1]
    C0946444
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    Similar models

    Study Conclusion Follow- Up (Visit 10)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    STUDY CONCLUSION
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Study Conclusion
    Item
    Did the subject complete the study as planned?
    boolean
    C1707478 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Item
    If ’NO’, mark the one most appropriate category
    integer
    C1707478 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Study Conclusion
    Code List
    If ’NO’, mark the one most appropriate category
    CL Item
    Adverse Event (complete Adverse Event Form) (1)
    C0877248 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Insufficient therapeutic effect (2)
    C1527144 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Deviation from Protocol (including non-compliance) (3)
    C1321605 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lost to Follow-Up (4)
    C1302313 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (5)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    Other
    Item
    Other, Please specify
    text
    C0205394 (UMLS CUI [1])
    Comment reason for withdrawal
    Item
    Comments on reason for withdrawal:
    text
    C0947611 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    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
    C1531784 (UMLS CUI [1])
    Time of Final Dose
    Item
    Time of Final Dose:
    time
    C0946444 (UMLS CUI [1])
    Back to the top of the page 

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