ID

34065

Beschreibung

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

Stichworte

Versionen (3)
  1. 08.01.19 08.01.19 -
  2. 10.01.19 10.01.19 -
  3. 14.01.19 14.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

14. Januar 2019

DOI

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Lizenz

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

Englisch

Randomisation Number, investigational product

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment period
Beschreibung

Only for the investigational product form.

Datentyp

integer

Alias
UMLS CUI [1]
C0087111
Day of Treatment period
Beschreibung

Only for the investigational product form.

Datentyp

integer

Alias
UMLS CUI [1]
C0087111
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschreibung

Ability of randomisation

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
If subject was able to be randomised, please note randomisation number
Beschreibung

Randomisation number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
If subject was able to be randomised, please note Date of randomisation
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational product - Container Number
Beschreibung

Investigational product - Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
Container Number
Beschreibung

Record the identifying number from the investigational product container dispensed at this visit. Fill in the following items for each container numbers.

Datentyp

integer

Alias
UMLS CUI [1]
C0180098
lnvestigational product container number
Beschreibung

lnvestigational product container number

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Container Label
Beschreibung

Container Label

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Investigational product - Day 1-7, treatment confirmation
Beschreibung

Investigational product - Day 1-7, treatment confirmation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0750484
UMLS CUI-3
C0087111
Start Date of dose
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of dose
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Correct treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If no correct treatment, note reason(s)
Beschreibung

Reason for no correct treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C2349182
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Ähnliche Modelle

Randomisation Number, investigational product

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Treatment period
integer
C0087111 (UMLS CUI [1])
Day of Treatment period
Code List
Treatment period
CL Item
TP1 (1)
CL Item
TP2 (2)
CL Item
TP4 (4)
CL Item
TP3 (3)
Item
Day of Treatment period
integer
C0087111 (UMLS CUI [1])
Day of Treatment period
Code List
Day of Treatment period
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (4)
CL Item
Day 4 (3)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Day 7 (7)
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Ability of randomisation
Code List
Was the subject able to be randomised?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation number
Item
If subject was able to be randomised, please note randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
If subject was able to be randomised, please note Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational product - Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
Item
Container Number
integer
C0180098 (UMLS CUI [1])
Container Number
Code List
Container Number
CL Item
Container Number 1 (1)
CL Item
Container Number 2 (2)
lnvestigational product container number
Item
lnvestigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Container Label
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Container Label
Code List
Container Label
CL Item
Inhaler A (1)
CL Item
Inhaler B (2)
Item Group
Investigational product - Day 1-7, treatment confirmation
C0304229 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
Start Date of dose
Item
Start Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Correct treatment
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
Reason for no correct treatment
Item
If no correct treatment, note reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,4])
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