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ID

25667

Descrizione

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.

Keywords

  1. 25/08/17 25/08/17 -
  2. 08/09/17 08/09/17 -
Caricato su

8 settembre 2017

DOI

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Licenza

Creative Commons BY-NC 3.0

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    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    General information
    Descrizione

    General information

    Protocol identifier
    Descrizione

    Protocol identifier

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2826693
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Description
    Descrizione

    Visit Description

    Tipo di dati

    text

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

    Pregnancy information

    Did the subject become pregnant during the study?
    Descrizione

    If Yes, complete Pregnancy Notification form.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0032961
    Study conclusion
    Descrizione

    Study conclusion

    Date of subject completion or withdrawal
    Descrizione

    Date

    Tipo di dati

    date

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    Was the subject withdrawn from the study?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

    Withdrawal

    Tipo di dati

    boolean

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

    reason withdrawal

    Tipo di dati

    text

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

    other reason withdrawal

    Tipo di dati

    text

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

    Investigator comment log

    CRF page number if applicable
    Descrizione

    CRF page number

    Tipo di dati

    integer

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

    Comment

    Tipo di dati

    text

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

    Investigator's signature

    Investigator’s Signature
    Descrizione

    Investigator Signature

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Descrizione

    signature date

    Tipo di dati

    date

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

    Investigator name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826892

    Similar models

    Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    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])
    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])

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