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ID

32730

Descrição

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

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Versões (1)
  1. 13/11/2018 13/11/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

13 de novembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Inglês

    PGx-Pharmacogenetic Research Consent

    1 Formulários  
    PGx-Pharmacogenetic Research Consent
    Descrição

    PGx-Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    Descrição

    Pharmacogenetic Test, Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    Date informed consent obtained for PGx-Pharmacogenetic research
    Descrição

    Pharmacogenetic Test, Informed Consent, Date in time

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0011008
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    Descrição

    Pharmacogenetic Test, Informed Consent, Indication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Descrição

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0005834
    Date sample taken
    Descrição

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    Withdrawal of Consent for PGx (DNA) Sample Destruction
    Descrição

    Withdrawal of Consent for PGx (DNA) Sample Destruction

    Alias
    UMLS CUI-1
    C0444245
    UMLS CUI-2
    C1948029
    UMLS CUI-3
    C1707492
    Has subject withdrawn consent for PGx research?
    Descrição

    Pharmacogenetic Test, Consent withdrawn

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1707492
    Date informed consent withdrawn
    Descrição

    Pharmacogenetic Test, Consent withdrawn, Date in time

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1707492
    UMLS CUI [1,3]
    C0011008
    Has a request been made for sample destruction?
    Descrição

    DNA sample, Destruction, Request

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0444245
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    Has a request been made for sample destruction? - Reason
    Descrição

    DNA sample, Destruction, Request, Indication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0444245
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
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    Similar models

    PGx-Pharmacogenetic Research Consent

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    PGx-Pharmacogenetic Research Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    Pharmacogenetic Test, Informed Consent
    Item
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Pharmacogenetic Test, Informed Consent, Date in time
    Item
    Date informed consent obtained for PGx-Pharmacogenetic research
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Pharmacogenetic Test, Informed Consent, Indication
    Code List
    No informed consent for PGx- Pharmacogenetic research obtained - Reason
    CL Item
    Subject declined (Subject declined)
    CL Item
    Subject not asked by Investigator (Subject not asked by Investigator)
    CL Item
    Other (Other)
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C0031325 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date sample taken
    date
    C0031325 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Withdrawal of Consent for PGx (DNA) Sample Destruction
    C0444245 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C1707492 (UMLS CUI-3)
    Pharmacogenetic Test, Consent withdrawn
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    Pharmacogenetic Test, Consent withdrawn, Date in time
    Item
    Date informed consent withdrawn
    date
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    DNA sample, Destruction, Request
    Item
    Has a request been made for sample destruction?
    boolean
    C0444245 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    Has a request been made for sample destruction? - Reason
    text
    C0444245 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    DNA sample, Destruction, Request, Indication
    Code List
    Has a request been made for sample destruction? - Reason
    CL Item
    Subject withdrew consent for PGx (Subject withdrew consent for PGx)
    CL Item
    Screen failure (Screen failure)
    CL Item
    Other (Other)
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