ID

32734

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

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

DOI

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License

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

English

IP Compliance

1 forms  
  1. StudyEvent: ODM
    1. IP Compliance
IP Compliance Returned
Description

IP Compliance Returned

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

Experimental Drug, Return, Dispense

Data type

text

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

Experimental Drug, Return, Date in time

Data type

date

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

Experimental Drug, Blister Pack, First, Number

Data type

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
Description

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

Data type

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
Description

Experimental Drug, Dispense, Blister Pack, Second, Number

Data type

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
Description

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

Data type

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?
Description

Experimental Drug, Medication Taken

Data type

boolean

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

Experimental Drug, Medication Taken, Number

Data type

integer

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

IP Compliance Dispensed

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

Experimental Drug, Dispense, Date in time

Data type

date

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

Experimental Drug, Blister Pack, First, Number

Data type

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
Description

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

Data type

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
Description

Experimental Drug, Blister Pack, Second, Number

Data type

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
Description

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

Data type

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
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Similar models

IP Compliance

1 forms
  1. StudyEvent: ODM
    1. IP Compliance
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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