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

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
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

Anglais

IP Compliance

1 Formulaires  
  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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Experimental Drug, Medication Taken, Number

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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
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 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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial