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ID

33967

Beschrijving

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 informations about the subjects eligibility. It should be filled out at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

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Versies (3)
  1. 03-12-18 03-12-18 -
  2. 18-12-18 18-12-18 -
  3. 09-01-19 09-01-19 -
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GlaxoSmithKline

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9 januari 2019

DOI

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

    Engels

    Eligibility Review on Admission

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Beschrijving

    Subject Screening No.

    Datatype

    integer

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

    Subject Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study Visit
    Beschrijving

    Study Visit

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0545082
    Eligibility Review on Admission
    Beschrijving

    Eligibility Review on Admission

    Alias
    UMLS CUI-1
    C0013893
    UMLS CUI-2
    C0030673
    Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
    Beschrijving

    If No, please give the reason below

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C1512693
    If no, please give reason below.
    Beschrijving

    Comment if the subject does not satisfy the inclusion/exclusion criteria of this study protocol.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0680251
    UMLS CUI [1,3]
    C0231175
    UMLS CUI [2,1]
    C0947611
    UMLS CUI [2,2]
    C1512693
    UMLS CUI [2,3]
    C0231175
    Was the sponsor contacted about the subject’s eligibility?
    Beschrijving

    Sponsor contacted about Eligibility

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C2347796
    UMLS CUI [1,3]
    C0013893
    If Yes, please give details below and append the Sponsor’s reply to the CRF
    Beschrijving

    Comment if the sponsor was contacted about the subject’s eligibility

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C2347796
    UMLS CUI [1,4]
    C0013893
    UMLS CUI [1,5]
    C0231175
    Will the subject proceed to dosing?
    Beschrijving

    Proceed Dosage

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0549178
    If No, give reason below
    Beschrijving

    Comment if the subject will not proceed to dosing?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0549178
    UMLS CUI [1,4]
    C0947611
    UMLS CUI [1,5]
    C0231175
    Date of Eligibility Review
    Beschrijving

    Eligibility Review

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013893
    Physician's Initials
    Beschrijving

    Physician's Initials

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Informed Consent
    Beschrijving

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    I confirm that the correct version of the study specific Informed Consent document has been signed and dated by the subject
    Beschrijving

    Informed Consent Obtained

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Date consent for study participation signed
    Beschrijving

    Informed Consent Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Physician's Initials
    Beschrijving

    Physician's Initials

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Terug naar het begin van de pagina

    Similar models

    Eligibility Review on Admission

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    Study Visit
    text
    C0545082 (UMLS CUI [1])
    Study Visit
    Code List
    Study Visit
    CL Item
    Treatment Period 1 (Treatment Period 1)
    CL Item
    Treatment Period 2 (Treatment Period 2)
    CL Item
    Treatment Period 3 (Treatment Period 3)
    Item Group
    Eligibility Review on Admission
    C0013893 (UMLS CUI-1)
    C0030673 (UMLS CUI-2)
    Inclusion/Exclusion Criteria
    Item
    Does the subject satisfy the inclusion/exclusion criteria of this study protocol?
    boolean
    C0680251 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    Inclusion/Exclusion Criteria Comment
    Item
    If no, please give reason below.
    text
    C0947611 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [2,1])
    C1512693 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    Sponsor contacted about Eligibility
    Item
    Was the sponsor contacted about the subject’s eligibility?
    boolean
    C0332158 (UMLS CUI [1,1])
    C2347796 (UMLS CUI [1,2])
    C0013893 (UMLS CUI [1,3])
    Sponsor contacted about Eligibility Comment
    Item
    If Yes, please give details below and append the Sponsor’s reply to the CRF
    text
    C0947611 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C2347796 (UMLS CUI [1,3])
    C0013893 (UMLS CUI [1,4])
    C0231175 (UMLS CUI [1,5])
    Proceed Dosage
    Item
    Will the subject proceed to dosing?
    boolean
    C0178602 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Proceed Dosage Comment
    Item
    If No, give reason below
    text
    C0947611 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    C0231175 (UMLS CUI [1,5])
    Eligibility Review
    Item
    Date of Eligibility Review
    date
    C0011008 (UMLS CUI [1,1])
    C0013893 (UMLS CUI [1,2])
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Item Group
    Informed Consent
    C0021430 (UMLS CUI-1)
    Informed Consent Obtained
    Item
    I confirm that the correct version of the study specific Informed Consent document has been signed and dated by the subject
    boolean
    C0021430 (UMLS CUI [1])
    Informed Consent Date
    Item
    Date consent for study participation signed
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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