ID

33932

Descrizione

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.

collegamento

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

Keywords

  1. 08/01/19 08/01/19 -
  2. 10/01/19 10/01/19 - Sarah Riepenhausen
  3. 10/01/19 10/01/19 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

8 gennaio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

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

Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
C2347500 C1707492
Descrizione

C2347500 C1707492

Has subject withdrawn consent for PGx research?
Descrizione

Withdrawl of consent for PGx

Tipo di dati

text

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If consent for PGx was withdrawn, please note the date of informed consent withdrawn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

day month year

Tipo di dati

date

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

Request to sample destruction

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Other reason for request to sample destruction

Tipo di dati

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
Descrizione

Design Notes

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

For PGx (DNA) is optional.

Tipo di dati

boolean

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

Similar models

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

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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])
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])
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])
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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