ID

33956

Beskrivning

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Meal form. It has to be filled in for TP1 D-1, TP1-4 day 7 for each.

Länk

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Nyckelord

Versioner (1)
  1. 2019-01-09 2019-01-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Engelsk

Meal

1 Formulär  
  1. StudyEvent: ODM
    1. Meal
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Treatment period and Day
Beskrivning

Treatment period and Day

Datatyp

integer

Alias
UMLS CUI [1]
C0087111
Dosing date and time
Beskrivning

Dosing date and time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
(Dummy) Dosing Date [read only]
Beskrivning

day month year Item is not required. Dummy dosage only for TP1D-1. For Day 7: investigational product dosage.

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0032042
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0011008
Dummy Dosing Time [read only]
Beskrivning

00:00-23:59 Item is not required. Dummy dosage only for TP1D-1. For Day 7: investigational product dosage.

Datatyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0032042
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Meal
Beskrivning

Meal

Alias
UMLS CUI-1
C1998602
Hours
Beskrivning

Hours

Datatyp

integer

Alias
UMLS CUI [1]
C0439227
Meal start time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C1301880
Meal end time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C1522314
Has the totality of the meal been ingested?
Beskrivning

Ingestion of meal

Datatyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
If no total ingestion of meal, please note percentage of meal consumed
Beskrivning

Percentage of meal consumed

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C1998602
Tillbaka till toppen

Similar models

Meal

1 Formulär
  1. StudyEvent: ODM
    1. Meal
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Treatment period and Day
integer
C0087111 (UMLS CUI [1])
Treatment type/Treatment period and Day
Code List
Treatment period and Day
CL Item
TP1D-1 (1)
CL Item
TP1D7  (2)
CL Item
TP3D7 (4)
CL Item
TP2D7 (3)
CL Item
TP4D7 (5)
Item Group
Dosing date and time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
(Dummy) Dosing Date
Item
(Dummy) Dosing Date [read only]
date
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0032042 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Dummy Dosing Time
Item
Dummy Dosing Time [read only]
time
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0032042 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Meal
C1998602 (UMLS CUI-1)
Item
Hours
integer
C0439227 (UMLS CUI [1])
Hours
Code List
Hours
CL Item
4 hours (1)
CL Item
8 hours (2)
CL Item
12 hours (3)
Meal start time
Item
Meal start time
time
C3842710 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Meal end time
Item
Meal end time
time
C3842710 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Has the totality of the meal been ingested?
text
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Ingestion of meal
Code List
Has the totality of the meal been ingested?
CL Item
Yes (Y)
CL Item
No (N)
Item
If no total ingestion of meal, please note percentage of meal consumed
integer
C0439165 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
No totaliy ingestion of meal
Code List
If no total ingestion of meal, please note percentage of meal consumed
CL Item
0 % (0)
CL Item
1-25 % (1)
CL Item
26-50 % (2)
CL Item
51-75% (3)
CL Item
76-100% (4)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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