0 Bedömningar
ID

32543

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. 2018-11-06 2018-11-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 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

    Study Conclusion

    1 Formulär  
    1. StudyEvent: ODM
      1. Study Conclusion
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C1707478 (Conclusion)
    Date of last contact
    Beskrivning

    Date last contact

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    Was the subject withdrawn from the study?
    Beskrivning

    Patient withdrawn from trial

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Date of decision to withdraw
    Beskrivning

    Patient withdrawn from trial; Decision, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0679006 (Decision)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Primary reason for withdrawal
    Beskrivning

    Patient withdrawn from trial; Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3146298 (Indication)
    Tillbaka till toppen

    Similar models

    Study Conclusion

    1 Formulär
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Date last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Patient withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Patient withdrawn from trial; Decision, Date in time
    Item
    Date of decision to withdraw
    date
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Patient withdrawn from trial; Indication
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol deviation (3)
    CL Item
    Subject reached protocol defined stopping criteria  (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion (7)
    CL Item
    Withdrew consent (8)
    CL Item
    Failure to complete PK portion of trial. (9)
    Tillbaka till toppen 

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