ID
34065
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Palabras clave
Versiones (3)
- 8/1/19 8/1/19 -
- 10/1/19 10/1/19 -
- 14/1/19 14/1/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
14 de enero de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Descripción
Ability of randomisation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Descripción
Randomisation number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Descripción
Investigational product - Container Number
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0180098
Descripción
Record the identifying number from the investigational product container dispensed at this visit. Fill in the following items for each container numbers.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0180098
Descripción
lnvestigational product container number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Descripción
Container Label
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Descripción
Investigational product - Day 1-7, treatment confirmation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0750484
- UMLS CUI-3
- C0087111
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Descripción
Correct treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
Descripción
Reason for no correct treatment
Tipo de datos
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])