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ID

33334

Description

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 study conclusion.

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Versions (2)
  1. 05/12/2018 05/12/2018 -
  2. 25/12/2018 25/12/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

5 décembre 2018

DOI

Pour une demande vous connecter.

Licence

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

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    Study Conclusion

    1 Formulaires  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Screening number
    Description

    Subject Screening No.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Description

    Date of Completion or Withdrawal

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    UMLS CUI [2,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2,2]
    C2349954 (Withdraw (activity))
    Time of Withdrawal
    Description

    Time of Withdrawal

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Was the subject withdrawn from the study?
    Description

    If Yes, tick the primary reason for withdrawal

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
    Reason for Withdrawal
    Description

    Tick primary reason for withdrawal

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason, specify
    Description

    Other Reason Specification

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,3]
    C1521902 (To specify)
    Did the subject become pregnant during the study?
    Description

    Pregnancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Additional Information
    Description

    Additional Information

    Alias
    UMLS CUI-1
    C1546922 (Additional information)
    Is there any additional information to be added to the subject’s CRF?
    Description

    Additional Information

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1546922 (Additional information)
    Comment Additional Information
    Description

    Comment Additional Information

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1546922 (Additional information)
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Investigator Statement
    Description

    Investigator Statement

    To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
    Description

    Signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Date
    Description

    Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Retour au début de la page

    Similar models

    Study Conclusion

    1 Formulaires
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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 Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Date of Completion or Withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C2349954 (UMLS CUI [2,2])
    Time of Withdrawal
    Item
    Time of Withdrawal
    time
    C2349954 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Withdrawal
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    Reason for Withdrawal
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for Withdrawal
    Code List
    Reason for Withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lost to follow up (2)
    CL Item
    Protocol Violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated the study (5)
    CL Item
    Other (6)
    Other Reason Specification
    Item
    If other reason, specify
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Pregnancy
    Item
    Did the subject become pregnant during the study?
    boolean
    C0032961 (UMLS CUI [1])
    Item Group
    Additional Information
    C1546922 (UMLS CUI-1)
    Additional Information
    Item
    Is there any additional information to be added to the subject’s CRF?
    boolean
    C1546922 (UMLS CUI [1])
    Comment Additional Information
    Item
    Comment Additional Information
    text
    C1546922 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Investigator Statement
    Signature
    Item
    To the best of my knowledge, the data in this CRF have been entered or transcribed by trained and experienced staff, submitted to a full quality control and/or plausibility check, and are correct at the date of signing.
    text
    C1519316 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Retour au début de la page 

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