0 Bedömningar
ID

33449

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 information about any concomitant medication the subject used during the study. It should be filled out at each visit. 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 (4)
  1. 1/12/18 1/12/18 -
  2. 9/12/18 9/12/18 -
  3. 21/1/19 21/1/19 -
  4. 25/1/19 25/1/19 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 de diciembre de 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

    Concomitant Medication

    1 Formulär  
    1. StudyEvent: ODM
      1. Concomitant Medication
    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
    Study Visit
    Beskrivning

    Study Visit

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0545082
    Concomitant Medication
    Beskrivning

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    Beskrivning

    f yes, record details below. Paracetamol for mild analgesia may be permitted

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C3166216
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C0013231
    UMLS CUI [3,1]
    C0332257
    UMLS CUI [3,2]
    C0042890
    UMLS CUI [4,1]
    C0332257
    UMLS CUI [4,2]
    C1360419
    UMLS CUI [5,1]
    C0332257
    UMLS CUI [5,2]
    C0003138
    Concomitant Medication Details
    Beskrivning

    Concomitant Medication Details

    Alias
    UMLS CUI-1
    C2347852
    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    Start Time
    Beskrivning

    If known

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C2347852
    Medication
    Beskrivning

    Generic/Brand

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2347852
    Dose
    Beskrivning

    Dose

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C2347852
    Units
    Beskrivning

    Units

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C2347852
    Route
    Beskrivning

    Route

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Frequency
    Beskrivning

    Frequency

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C2347852
    Indication
    Beskrivning

    Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C2347852
    Medication Ongoing
    Beskrivning

    Medication Ongoing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    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
    Tillbaka till toppen

    Similar models

    Concomitant Medication

    1 Formulär
    1. StudyEvent: ODM
      1. Concomitant Medication
    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
    Study Visit
    text
    C0545082 (UMLS CUI [1])
    Study Visit
    Code List
    Study Visit
    CL Item
    Screening (Screening)
    CL Item
    Treatment Period 1 (Treatment Period 1)
    CL Item
    Treatment Period 2 (Treatment Period 2)
    CL Item
    Treatment Period 3 (Treatment Period 3)
    CL Item
    Follow-Up Visit (Follow-Up Visit)
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Item
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    text
    C0332185 (UMLS CUI [1,1])
    C3166216 (UMLS CUI [1,2])
    C0332185 (UMLS CUI [2,1])
    C0013231 (UMLS CUI [2,2])
    C0332257 (UMLS CUI [3,1])
    C0042890 (UMLS CUI [3,2])
    C0332257 (UMLS CUI [4,1])
    C1360419 (UMLS CUI [4,2])
    C0332257 (UMLS CUI [5,1])
    C0003138 (UMLS CUI [5,2])
    Prescribed or Non-Prescribed Medication, including Vitamins, Herbal Remedies and Antacids
    Code List
    Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    CL Item
    N/A (N/A)
    Item Group
    Concomitant Medication Details
    C2347852 (UMLS CUI-1)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Start Time
    Item
    Start Time
    datetime
    C1301880 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication
    Item
    Medication
    text
    C0013227 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication Ongoing
    Item
    Medication Ongoing
    boolean
    C2826666 (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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