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ID

33524

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 information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed 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

Trefwoorden

  1. 11-12-18 11-12-18 -
  2. 11-12-18 11-12-18 -
  3. 08-01-19 08-01-19 -
  4. 23-01-19 23-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    1. StudyEvent: ODM
      1. ECG
    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
    Date Information Collected
    Beschrijving

    Date Information Collected

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3244127
    UMLS CUI [1,2]
    C0011008
    12- Lead Electrocardiogram
    Beschrijving

    12- Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Please record RR value
    Beschrijving

    Blood pressure

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0005823
    Result of ECG one
    Beschrijving

    If ECG abnormal and clinically significant, exclude

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0438154
    ECG comment
    Beschrijving

    ECG comment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0947611
    Unscheduled 12-Lead Electrocardiogram
    Beschrijving

    Unscheduled 12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C3854240
    Actual Time
    Beschrijving

    Actual Time

    Datatype

    time

    Alias
    UMLS CUI [1]
    C0040223
    Please Record RR Value
    Beschrijving

    RR Value

    Datatype

    integer

    Maateenheden
    • ms
    Alias
    UMLS CUI [1]
    C0489636
    ms
    ECG Result
    Beschrijving

    Tick only one

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Comment
    Beschrijving

    Please enter reason for repeat of ECG.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    Conclusion
    Beschrijving

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Staff initials
    Beschrijving

    Staff initials

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C1552089

    Similar models

    1. StudyEvent: ODM
      1. ECG
    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])
    Date Information Collected
    Item
    Date Information Collected
    date
    C3244127 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    12- Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    Blood pressure
    Item
    Please record RR value
    integer
    C0005823 (UMLS CUI [1])
    Item
    Result of ECG one
    integer
    C0438154 (UMLS CUI [1])
    Code List
    Result of ECG one
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - clinically significant (3)
    CL Item
    No result (Not available) (4)
    ECG comment
    Item
    ECG comment
    text
    C1623258 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Unscheduled 12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    RR Value
    Item
    Please Record RR Value
    integer
    C0489636 (UMLS CUI [1])
    Item
    ECG Result
    integer
    C0438154 (UMLS CUI [1])
    Code List
    ECG Result
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically Significant (If Yes, Exclude (3)
    CL Item
    No result (not available) (4)
    Comment
    Item
    Comment
    text
    C0947611 (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])

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