ID

33932

Descrição

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 Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl) form. It has to be filled in for the end of study.

Link

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

Palavras-chave

Versões (3)
  1. 08/01/2019 08/01/2019 -
  2. 10/01/2019 10/01/2019 - Sarah Riepenhausen
  3. 10/01/2019 10/01/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

8 de janeiro de 2019

DOI

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Licença

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

Inglês

Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
C2347500 C1707492
Descrição

C2347500 C1707492

Has subject withdrawn consent for PGx research?
Descrição

Withdrawl of consent for PGx

Tipo de dados

text

Alias
UMLS CUI [1]
C1707492
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
Has a request been made for sample destruction?
Descrição

Request to sample destruction

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request to sample destruction was made, please check reasons
Descrição

Screen failure is an optional choice. Please replace 'insert sample type' with the appropriate sample type as specified in the protocol.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request sample destruction, please specify
Descrição

Other reason for request to sample destruction

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
Design Notes
Descrição

Design Notes

Alias
UMLS CUI-1
C0947611
Withdrawl of consent for PGx (DNA) sample destruction
Descrição

For PGx (DNA) is optional.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
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Similar models

Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1])
Withdrawl of consent for PGx
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent withdrawn
Item
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Request to sample destruction
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If request to sample destruction was made, please check reasons
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Request to sample destruction
Code List
If request to sample destruction was made, please check reasons
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Item
If other reason for request sample destruction, please specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Request to sample destruction
Code List
If other reason for request sample destruction, please specify
Item Group
Design Notes
C0947611 (UMLS CUI-1)
Withdrawl of consent for PGx (DNA) sample destruction
Item
Withdrawl of consent for PGx (DNA) sample destruction
boolean
C1707492 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
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