ID
34065
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 Randomisation Number form. It has to be filled in for TP1 Day 1. It also contains the investigational product form. It has to be filled in for all treatment periods. Day 1 and 7 have to be filled in by the study investigator. Day 2-6 have to be transcribed from subjects entries.
Länk
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Nyckelord
Versioner (3)
- 2019-01-08 2019-01-08 -
- 2019-01-10 2019-01-10 -
- 2019-01-14 2019-01-14 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
14 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Randomisation Number, investigational product
- StudyEvent: ODM
Beskrivning
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beskrivning
Ability of randomisation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Beskrivning
Randomisation number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigational product - Container Number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
Beskrivning
Record the identifying number from the investigational product container dispensed at this visit. Fill in the following items for each container numbers.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0180098
Beskrivning
lnvestigational product container number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beskrivning
Container Label
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beskrivning
Investigational product - Day 1-7, treatment confirmation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0750484
- UMLS CUI-3
- C0087111
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beskrivning
Correct treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
Beskrivning
Reason for no correct treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C2349182
Similar models
Randomisation Number, investigational product
- StudyEvent: ODM
C0085732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0180098 (UMLS CUI-2)
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0750484 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])