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25667

Beschreibung

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Study conclusion.

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Versionen (2)
  1. 25.08.17 25.08.17 -
  2. 08.09.17 08.09.17 -
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8. September 2017

DOI

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    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    Englisch

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    1 Formulare  
    General information
    Beschreibung

    General information

    Protocol identifier
    Beschreibung

    Protocol identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826693
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Description
    Beschreibung

    Visit Description

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0678257
    Pregnancy information
    Beschreibung

    Pregnancy information

    Did the subject become pregnant during the study?
    Beschreibung

    If Yes, complete Pregnancy Notification form.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0032961
    Study conclusion
    Beschreibung

    Study conclusion

    Date of subject completion or withdrawal
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Was the subject withdrawn from the study?
    Beschreibung

    Withdrawal

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1519255
    If Yes, check the primary reason for withdrawal:
    Beschreibung

    reason withdrawal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    If other reason, specify
    Beschreibung

    other reason withdrawal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C3840932
    Investigator comment log
    Beschreibung

    Investigator comment log

    CRF page number if applicable
    Beschreibung

    CRF page number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C1516308
    UMLS CUI [1,3]
    C1515022
    Comment
    Beschreibung

    Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Investigator's signature
    Beschreibung

    Investigator's signature

    Investigator’s Signature
    Beschreibung

    Investigator Signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beschreibung

    signature date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0807937
    Investigator’s name (print)
    Beschreibung

    Investigator name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    General information
    Protocol identifier
    Item
    Protocol identifier
    integer
    C2826693 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Description
    Item
    Visit Description
    text
    C0545082 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item Group
    Pregnancy information
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Did the subject become pregnant during the study?
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    C0549206 (UMLS CUI-1)
    (Comment:en)
    CL Item
    No (N)
    C0232973 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not Applicable (not of childbearing potential or male) (x)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item Group
    Study conclusion
    Date
    Item
    Date of subject completion or withdrawal
    date
    C0011008 (UMLS CUI [1])
    Withdrawal
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    If Yes, check the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    reason withdrawal
    Code List
    If Yes, check the primary reason for withdrawal:
    CL Item
    Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
    C0877248 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lost to follow-up (2)
    C1302313 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Protocol violation (3)
    C1709750 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject decided to withdraw from the study (4)
    C2348571 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lack of efficacy (5)
    C0235828 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sponsor terminated study (6)
    C1710224 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Dyskinesia (28)
    C0013384 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (Z)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    other reason withdrawal
    Item
    If other reason, specify
    text
    C2349954 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Investigator comment log
    CRF page number
    Item
    CRF page number if applicable
    integer
    C0237753 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    C1515022 (UMLS CUI [1,3])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's signature
    Investigator Signature
    Item
    Investigator’s Signature
    text
    C2346576 (UMLS CUI [1])
    signature date
    Item
    Date
    date
    C0807937 (UMLS CUI [1])
    Investigator name
    Item
    Investigator’s name (print)
    text
    C2826892 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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