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ID

32734

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

    IP Compliance

    1 Formulär  
    1. StudyEvent: ODM
      1. IP Compliance
    IP Compliance Returned
    Beskrivning

    IP Compliance Returned

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1321605
    UMLS CUI-3
    C0332156
    Returned IP was Dispensed at
    Beskrivning

    Experimental Drug, Return, Dispense

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0332156
    UMLS CUI [1,3]
    C1880359
    IP return date
    Beskrivning

    Experimental Drug, Return, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0332156
    UMLS CUI [1,3]
    C0011008
    First Blister Card Number
    Beskrivning

    Experimental Drug, Blister Pack, First, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1706080
    UMLS CUI [1,3]
    C0205435
    UMLS CUI [1,4]
    C0237753
    Total number of tablets returned from first blister card
    Beskrivning

    Experimental Drug, Blister Pack, First, Count of entities, Return

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1706080
    UMLS CUI [1,3]
    C0205435
    UMLS CUI [1,4]
    C0449788
    UMLS CUI [1,5]
    C0332156
    Second Blister Card Number
    Beskrivning

    Experimental Drug, Dispense, Blister Pack, Second, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1880359
    UMLS CUI [1,3]
    C1706080
    UMLS CUI [1,4]
    C0205436
    UMLS CUI [1,5]
    C0237753
    Total Number of Tablets from second blister card dispensed
    Beskrivning

    Experimental Drug, Blister Pack, Second, Count of entities, Return

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1706080
    UMLS CUI [1,3]
    C0205436
    UMLS CUI [1,4]
    C0449788
    UMLS CUI [1,5]
    C0332156
    Has the subject taken all the medication not returned?
    Beskrivning

    Experimental Drug, Medication Taken

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1290952
    If no, specify number taken
    Beskrivning

    Experimental Drug, Medication Taken, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1290952
    UMLS CUI [1,3]
    C0237753
    IP Compliance Dispensed
    Beskrivning

    IP Compliance Dispensed

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1321605
    UMLS CUI-3
    C1880359
    Date Dispensed
    Beskrivning

    Experimental Drug, Dispense, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1880359
    UMLS CUI [1,3]
    C0011008
    First Blister Card Number
    Beskrivning

    Experimental Drug, Blister Pack, First, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1706080
    UMLS CUI [1,3]
    C0205435
    UMLS CUI [1,4]
    C0237753
    Total Number of Tablets Dispensed from first Blister card
    Beskrivning

    Experimental Drug, Dispense, Blister Pack, First, Count of entities

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1880359
    UMLS CUI [1,3]
    C1706080
    UMLS CUI [1,4]
    C0205435
    UMLS CUI [1,5]
    C0449788
    Second Blister Card Number
    Beskrivning

    Experimental Drug, Blister Pack, Second, Number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1706080
    UMLS CUI [1,3]
    C0205436
    UMLS CUI [1,4]
    C0237753
    Total Number of Tablets Dispensed from second Blister card
    Beskrivning

    Experimental Drug, Dispense, Blister Pack, Second, Count of entities

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1880359
    UMLS CUI [1,3]
    C1706080
    UMLS CUI [1,4]
    C0205436
    UMLS CUI [1,5]
    C0449788
    Tillbaka till toppen

    Similar models

    IP Compliance

    1 Formulär
    1. StudyEvent: ODM
      1. IP Compliance
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    IP Compliance Returned
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C0332156 (UMLS CUI-3)
    Experimental Drug, Return, Dispense
    Item
    Returned IP was Dispensed at
    text
    C0304229 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    C1880359 (UMLS CUI [1,3])
    Experimental Drug, Return, Date in time
    Item
    IP return date
    date
    C0304229 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Experimental Drug, Blister Pack, First, Number
    Item
    First Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Experimental Drug, Blister Pack, First, Count of entities, Return
    Item
    Total number of tablets returned from first blister card
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C0449788 (UMLS CUI [1,4])
    C0332156 (UMLS CUI [1,5])
    Experimental Drug, Dispense, Blister Pack, Second, Number
    Item
    Second Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C1706080 (UMLS CUI [1,3])
    C0205436 (UMLS CUI [1,4])
    C0237753 (UMLS CUI [1,5])
    Experimental Drug, Blister Pack, Second, Count of entities, Return
    Item
    Total Number of Tablets from second blister card dispensed
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205436 (UMLS CUI [1,3])
    C0449788 (UMLS CUI [1,4])
    C0332156 (UMLS CUI [1,5])
    Experimental Drug, Medication Taken
    Item
    Has the subject taken all the medication not returned?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1290952 (UMLS CUI [1,2])
    Experimental Drug, Medication Taken, Number
    Item
    If no, specify number taken
    integer
    C0304229 (UMLS CUI [1,1])
    C1290952 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Item Group
    IP Compliance Dispensed
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C1880359 (UMLS CUI-3)
    Experimental Drug, Dispense, Date in time
    Item
    Date Dispensed
    date
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Experimental Drug, Blister Pack, First, Number
    Item
    First Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Experimental Drug, Dispense, Blister Pack, First, Count of entities
    Item
    Total Number of Tablets Dispensed from first Blister card
    integer
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C1706080 (UMLS CUI [1,3])
    C0205435 (UMLS CUI [1,4])
    C0449788 (UMLS CUI [1,5])
    Experimental Drug, Blister Pack, Second, Number
    Item
    Second Blister Card Number
    integer
    C0304229 (UMLS CUI [1,1])
    C1706080 (UMLS CUI [1,2])
    C0205436 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Experimental Drug, Dispense, Blister Pack, Second, Count of entities
    Item
    Total Number of Tablets Dispensed from second Blister card
    integer
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C1706080 (UMLS CUI [1,3])
    C0205436 (UMLS CUI [1,4])
    C0449788 (UMLS CUI [1,5])
    Tillbaka till toppen 

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