0 Evaluaciones
ID

33765

Descripción

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.

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Versiones (2)
  1. 5/12/18 5/12/18 -
  2. 25/12/18 25/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de diciembre de 2018

DOI

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Licencia

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

    Inglés

    Study Conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Screening number
    Descripción

    Subject Screening No.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Descripción

    Subject Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Descripción

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Descripción

    Date of Completion or Withdrawal

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    UMLS CUI [2,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2,2]
    C2349954 (Withdraw (activity))
    Time of Withdrawal
    Descripción

    Time of Withdrawal

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Was the subject withdrawn from the study?
    Descripción

    If Yes, tick the primary reason for withdrawal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
    Reason for Withdrawal
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason, specify
    Descripción

    Other Reason Specification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,3]
    C1521902 (To specify)
    Did the subject become pregnant during the study?
    Descripción

    Pregnancy

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Physician's Initials
    Descripción

    Physician's Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C0031831 (Physicians)
    SNOMED
    158965000
    LOINC
    LA18968-0
    Additional Information
    Descripción

    Additional Information

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

    Additional Information

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1546922 (Additional information)
    Comment Additional Information
    Descripción

    If Yes, provide details below

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1546922 (Additional information)
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Physician's Initials
    Descripción

    Physician's Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2986440 (Person Initials)
    UMLS CUI [1,2]
    C0031831 (Physicians)
    SNOMED
    158965000
    LOINC
    LA18968-0
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Investigator Statement
    Descripción

    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.
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Study Conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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