0 Evaluaciones
ID

36208

Descripción

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

Palabras clave

Versiones (1)
  1. 22/4/19 22/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de abril de 2019

DOI

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Licencia

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

    Inglés

    Investigational Product Discontinuation

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Investigational Product Discontinuation
    Descripción

    Investigational Product Discontinuation

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0457454 (Discontinuation (procedure))
    Was the investigational product stopped permanently before the end of the scheduled treatment period?
    Descripción

    Experimental drug, Discontinuation, Permanent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,3]
    C0205355 (Permanent)
    SNOMED
    6934004
    If Yes, tick the primary reason the investigational product was stopped
    Descripción

    Experimental drug, Discontinuation, Permanent, Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,3]
    C0205355 (Permanent)
    SNOMED
    6934004
    UMLS CUI [1,4]
    C4288399 (Pharmacotherapy Discontinuation)
    UMLS CUI [1,5]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
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    Similar models

    Investigational Product Discontinuation

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
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