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ID

36208

Description

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

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Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

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Creative Commons BY-NC 3.0
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    Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

    English

    Investigational Product Discontinuation

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Investigational Product Discontinuation
    Description

    Investigational Product Discontinuation

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0457454
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    Description

    Experimental drug, Discontinuation, Permanent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0205355
    If Yes, tick the primary reason the investigational product was stopped
    Description

    Experimental drug, Discontinuation, Permanent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0205355
    UMLS CUI [1,4]
    C4288399
    UMLS CUI [1,5]
    C0392360
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    Similar models

    Investigational Product Discontinuation

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Investigational Product Discontinuation
    C0304229 (UMLS CUI-1)
    C0457454 (UMLS CUI-2)
    Experimental drug, Discontinuation, Permanent
    Item
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0205355 (UMLS CUI [1,3])
    Item
    If Yes, tick the primary reason the investigational product was stopped
    text
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0205355 (UMLS CUI [1,3])
    C4288399 (UMLS CUI [1,4])
    C0392360 (UMLS CUI [1,5])
    Experimental drug, Discontinuation, Permanent, Indication
    Code List
    If Yes, tick the primary reason the investigational product was stopped
    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 [6] D Sponsor terminated study (4)
    CL Item
    Other (5)
    Back to the top of the page 

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