0 Bedömningar
ID

33452

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 result of the physical examination. It should be filled out at screening visit and updated throughout the study if necessary. 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

Nyckelord

Versioner (3)
  1. 2018-12-01 2018-12-01 -
  2. 2018-12-09 2018-12-09 -
  3. 2018-12-18 2018-12-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 december 2018

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

    Engelsk

    Physical Examination

    1 Formulär  
    1. StudyEvent: ODM
      1. Physical Examination
    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
    Date Information Collected
    Beskrivning

    Date Information Collected

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3244127
    UMLS CUI [1,2]
    C0011008
    Physical Examination
    Beskrivning

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Examination
    Beskrivning

    Examination

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0031809
    Examination Result
    Beskrivning

    Examination Result

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1274040
    If abnormal please describe
    Beskrivning

    Examination Result Abnormal

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0205161
    Examination Result Clinically Significant
    Beskrivning

    Examination Result Clinically Significant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0459424
    UMLS CUI [1,2]
    C2826634
    Is the subject healthy as determined by the clinical examination?
    Beskrivning

    Subject Healthy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3898900
    Conclusion
    Beskrivning

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Staff initials
    Beskrivning

    Staff initials

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089
    Physician's Initials
    Beskrivning

    Physician's Initials

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
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    Similar models

    Physical Examination

    1 Formulär
    1. StudyEvent: ODM
      1. Physical Examination
    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])
    Date Information Collected
    Item
    Date Information Collected
    date
    C3244127 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Examination
    text
    C0031809 (UMLS CUI [1])
    Examination Area
    Code List
    Examination
    CL Item
    HEENT (HEENT)
    CL Item
    Cardiovascular (Cardiovascular)
    CL Item
    Chest/Lungs (Chest/Lungs)
    CL Item
    Abdomen (Abdomen)
    CL Item
    Neurological (Neurological)
    CL Item
    Musculoskeletal (Musculoskeletal)
    CL Item
    Fundoscopy (Fundoscopy)
    CL Item
    Lymph (Lymph)
    CL Item
    Nodes (Nodes)
    CL Item
    Other (Other)
    CL Item
    General appearance (General appearance)
    CL Item
    Neck and Thyroid (Neck and Thyroid)
    CL Item
    Skin (incl. hair, nails) (Skin (incl. hair, nails))
    Item
    Examination Result
    text
    C0031809 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Examination Result
    Code List
    Examination Result
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not done (Not done)
    Examination Result Abnormal
    Item
    If abnormal please describe
    text
    C0031809 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0205161 (UMLS CUI [1,3])
    Examination Result Clinically Significant
    Item
    Examination Result Clinically Significant
    boolean
    C0459424 (UMLS CUI [1,1])
    C2826634 (UMLS CUI [1,2])
    Subject Healthy
    Item
    Is the subject healthy as determined by the clinical examination?
    boolean
    C3898900 (UMLS CUI [1])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Staff initials
    Item
    Staff initials
    text
    C2986440 (UMLS CUI [1,1])
    C1552089 (UMLS CUI [1,2])
    Physician's Initials
    Item
    Physician's Initials
    text
    C2986440 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Tillbaka till toppen 

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