ID

33956

Beschrijving

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.

Link

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

Trefwoorden

Versies (1)
  1. 09-01-19 09-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Engels

Meal

1 Formulieren  
  1. StudyEvent: ODM
    1. Meal
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

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

Treatment period and Day

Datatype

integer

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

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]
Beschrijving

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

Datatype

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]
Beschrijving

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

Datatype

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
Beschrijving

Meal

Alias
UMLS CUI-1
C1998602
Hours
Beschrijving

Hours

Datatype

integer

Alias
UMLS CUI [1]
C0439227
Meal start time
Beschrijving

00:00-23:59

Datatype

time

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

00:00-23:59

Datatype

time

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

Ingestion of meal

Datatype

text

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

Percentage of meal consumed

Datatype

integer

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C1998602
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Similar models

Meal

1 Formulieren
  1. StudyEvent: ODM
    1. Meal
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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