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ID

33765

Beskrivning

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains the study conclusion.

Nyckelord

Versioner (2)
  1. 2018-12-05 2018-12-05 -
  2. 2018-12-25 2018-12-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 december 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Engelsk

    Study Conclusion

    1 Formulär  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Beskrivning

    Subject Screening No.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0220908
    UMLS CUI [1,2]
    C0600091
    Subject no.
    Beskrivning

    Subject Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Beskrivning

    Date of Completion or Withdrawal

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2983670
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C2349954
    Time of Withdrawal
    Beskrivning

    Time of Withdrawal

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0040223
    Was the subject withdrawn from the study?
    Beskrivning

    If Yes, tick the primary reason for withdrawal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2349954
    Reason for Withdrawal
    Beskrivning

    Tick primary reason for withdrawal If Adverse Event, record details on the Non-Serious Adverse Events or Serious Adverse Events pages

    Datatyp

    integer

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

    Other Reason Specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Did the subject become pregnant during the study?
    Beskrivning

    Pregnancy

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0032961
    Physician's Initials
    Beskrivning

    Physician's Initials

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Additional Information
    Beskrivning

    Additional Information

    Alias
    UMLS CUI-1
    C1546922
    Is there any additional information to be added to the subject’s CRF?
    Beskrivning

    Additional Information

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1546922
    Comment Additional Information
    Beskrivning

    If Yes, provide details below

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1546922
    UMLS CUI [1,2]
    C0947611
    Physician's Initials
    Beskrivning

    Physician's Initials

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator Statement
    Beskrivning

    Investigator Statement

    To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
    Beskrivning

    Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519316
    Date
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    Study Conclusion

    1 Formulär
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Date of Completion or Withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C2349954 (UMLS CUI [2,2])
    Time of Withdrawal
    Item
    Time of Withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Withdrawal
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    Reason for Withdrawal
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for Withdrawal
    Code List
    Reason for Withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lost to follow up (2)
    CL Item
    Protocol Violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated the study (5)
    CL Item
    Other (6)
    Other Reason Specification
    Item
    If other reason, specify
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (not of childbearing potential or male) (X)
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Item Group
    Additional Information
    C1546922 (UMLS CUI-1)
    Additional Information
    Item
    Is there any additional information to be added to the subject’s CRF?
    boolean
    C1546922 (UMLS CUI [1])
    Comment Additional Information
    Item
    Comment Additional Information
    text
    C1546922 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Investigator Statement
    Signature
    Item
    To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
    text
    C1519316 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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