0 Évaluations
ID

32731

Description

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

Mots-clés

Versions (1)
  1. 13/11/2018 13/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

13 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

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    IP Compliance

    1 Formulaires  
    1. StudyEvent: ODM
      1. IP Compliance
    IP Compliance Dispensed
    Description

    IP Compliance Dispensed

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI-3
    C1880359 (Dispense (Activity))
    Planned Dispense Visit
    Description

    Experimental Drug, Dispense, Visit, Planned

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C0545082 (Visit)
    UMLS CUI [1,4]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Date Dispensed
    Description

    Experimental Drug, Dispense, Date in time

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Total Number of Tablets from first blister card dispensed
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,4]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,5]
    C0449788 (Count of entities)
    SNOMED
    410681005
    First Blister Card Number
    Description

    Experimental Drug, Blister Pack, First, Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,4]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Total Number of Tablets from second blister card dispensed
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,4]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,5]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Second Blister Card Number
    Description

    Experimental Drug, Blister Pack, Second, Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,4]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    IP Compliance Returned
    Description

    IP Compliance Returned

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI-3
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Planned Dispense Visit
    Description

    Experimental Drug, Dispense, Visit, Planned

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C0545082 (Visit)
    UMLS CUI [1,4]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    IP return date
    Description

    Experimental Drug, Return, Date in time

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    First Blister Card Number
    Description

    Experimental Drug, Blister Pack, First, Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,4]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Total number of tablets returned from first blister card
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,4]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,5]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Second Blister Card Number
    Description

    Experimental Drug, Dispense, Blister Pack, Second, Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1880359 (Dispense (Activity))
    UMLS CUI [1,3]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,4]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,5]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Total Number of Tablets from second blister card dispensed
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1706080 (Blister Pack - device)
    UMLS CUI [1,3]
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    UMLS CUI [1,4]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,5]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Has the subject taken all the medication not returned?
    Description

    Experimental Drug, Medication Taken

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    If no, specify number taken
    Description

    Experimental Drug, Medication Taken, Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    UMLS CUI [1,3]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Retour au début de la page

    Similar models

    IP Compliance

    1 Formulaires
    1. StudyEvent: ODM
      1. IP Compliance
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    IP Compliance Dispensed
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C1880359 (UMLS CUI-3)
    Experimental Drug, Dispense, Visit, Planned
    Item
    Planned Dispense Visit
    text
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    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, Dispense, Blister Pack, First, Count of entities
    Item
    Total Number of Tablets from first blister card dispensed
    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, 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, Second, Count of entities
    Item
    Total Number of Tablets from second blister card dispensed
    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])
    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])
    Item Group
    IP Compliance Returned
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C0332156 (UMLS CUI-3)
    Experimental Drug, Dispense, Visit, Planned
    Item
    Planned Dispense Visit
    text
    C0304229 (UMLS CUI [1,1])
    C1880359 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    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])
    Retour au début de la page 

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