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ID

32730

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-13 2018-11-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 november 2018

DOI

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Licens

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

    Engelsk

    PGx-Pharmacogenetic Research Consent

    1 Formulär  
    PGx-Pharmacogenetic Research Consent
    Beskrivning

    PGx-Pharmacogenetic Research Consent

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

    Pharmacogenetic Test, Informed Consent

    Datatyp

    boolean

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

    Pharmacogenetic Test, Informed Consent, Date in time

    Datatyp

    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
    Beskrivning

    Pharmacogenetic Test, Informed Consent, Indication

    Datatyp

    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?
    Beskrivning

    Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

    Datatyp

    boolean

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

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

    Datatyp

    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
    Beskrivning

    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?
    Beskrivning

    Pharmacogenetic Test, Consent withdrawn

    Datatyp

    boolean

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    Date informed consent withdrawn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

    Pharmacogenetic Test, Consent withdrawn, Date in time

    Datatyp

    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?
    Beskrivning

    DNA sample, Destruction, Request

    Datatyp

    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
    Beskrivning

    DNA sample, Destruction, Request, Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0444245
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    Tillbaka till toppen

    Similar models

    PGx-Pharmacogenetic Research Consent

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)
    Tillbaka till toppen 

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