0 Bewertungen
ID

33449

Beschreibung

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

Stichworte

Versionen (4)
  1. 01.12.18 01.12.18 -
  2. 09.12.18 09.12.18 -
  3. 21.01.19 21.01.19 -
  4. 25.01.19 25.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Dezember 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Englisch

    Concomitant Medication

    1 Formulare  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Beschreibung

    Subject Screening No.

    Datentyp

    integer

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

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date Information Collected
    Beschreibung

    Date Information Collected

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C3244127
    UMLS CUI [1,2]
    C0011008
    Study Visit
    Beschreibung

    Study Visit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0545082
    Concomitant Medication
    Beschreibung

    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.
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Concomitant Medication Details

    Alias
    UMLS CUI-1
    C2347852
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

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

    If known

    Datentyp

    datetime

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

    Generic/Brand

    Datentyp

    text

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

    Dose

    Datentyp

    text

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

    Units

    Datentyp

    text

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

    Route

    Datentyp

    text

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

    Frequency

    Datentyp

    text

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

    Indication

    Datentyp

    text

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

    Medication Ongoing

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Conclusion
    Beschreibung

    Conclusion

    Alias
    UMLS CUI-1
    C1707478
    Staff initials
    Beschreibung

    Staff initials

    Datentyp

    text

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

    Physician's Initials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0031831
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Concomitant Medication

    1 Formulare
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video