ID

33999

Description

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 Dummy Dose form. It has to be filled in for TP1-4 for each D-1.

Link

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

Keywords

Versions (2)
  1. 1/9/19 1/9/19 -
  2. 1/10/19 1/10/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2019

DOI

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License

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

English

Dummy Dose

1 forms  
  1. StudyEvent: ODM
    1. Dummy Dose
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

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

Treatment type/Treatment period and Day

Data type

integer

Alias
UMLS CUI [1]
C0087111
Dummy Dose
Description

Dummy Dose

Alias
UMLS CUI-1
C3174092
UMLS CUI-2
C0304229
Date of Dummy dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0032042
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dummy dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0032042
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
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Similar models

Dummy Dose

1 forms
  1. StudyEvent: ODM
    1. Dummy Dose
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
(Comment:en)
CL Item
TP2D-1 (2)
(Comment:en)
CL Item
TP3D-1 (3)
(Comment:en)
CL Item
TP4D-1 (4)
(Comment:en)
Item Group
Dummy Dose
C3174092 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Date of Dummy dose
Item
Date of Dummy dose
date
C0032042 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dummy dose
Item
Time of Dummy dose
time
C0032042 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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