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
UMLS CUI-2
C1707478
Date of last contact
Beskrivning

Date last contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beskrivning

Patient withdrawn from trial

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Beskrivning

Patient withdrawn from trial; Decision, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Beskrivning

Patient withdrawn from trial; Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
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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Patient withdrawn from trial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Was the subject withdrawn from the study?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Patient withdrawn from trial; Decision, Date in time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)
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