ID

29932

Beskrivning

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Investigational Product, Compliance and Treatment Blind.

Nyckelord

Versioner (1)
  1. 2018-04-27 2018-04-27 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Engelsk

Investigational Product and Treatment Blind

1 Formulär  
Investigational Product: Double-blind nasal spray
Beskrivning

Investigational Product: Double-blind nasal spray

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0461725
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational Product Compliance
Beskrivning

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Visit Investigational Product dispensed (double-blind nasal spray)
Beskrivning

Visit Investigational Product dispensed

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0545082
Date Investigational Product Dispensed
Beskrivning

Date Investigational Product Dispensed

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0304229
Weight of Investigational Product when dispensed
Beskrivning

Weight of Investigational Product when dispensed

Datatyp

float

Måttenheter
  • g
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0805077
UMLS CUI [1,3]
C0043100
g
Date investigational product returned
Beskrivning

Date investigational product returned

Datatyp

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2826249
Weight of investigational Product when returned
Beskrivning

Weight of investigational Product when returned

Datatyp

float

Måttenheter
  • g
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2699071
UMLS CUI [1,3]
C0043100
g
Investigational Product Replacement Container Numbers
Beskrivning

Investigational Product Replacement Container Numbers

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0559956
UMLS CUI-4
C0600091
Replacement Number (if used)
Beskrivning

Replacement Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559956
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0180098
Record the identifying number from the (replacement) investigational product container dispensed (if applicable) during the treatment period.
Beskrivning

Investigational Prodcut Container Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Status of Treatment Blind
Beskrivning

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Beskrivning

Treatment blind broken

Datatyp

text

Alias
UMLS CUI [1]
C3897431
If Treatment Blind was broken during the study, when?
Beskrivning

Date blind broken

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If Treatment Blind was broken during the study, why?
Beskrivning

Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason for breaking treatment blind, specify
Beskrivning

Other Reason blind broken

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
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Similar models

Investigational Product and Treatment Blind

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigational Product: Double-blind nasal spray
C0304229 (UMLS CUI-1)
C0461725 (UMLS CUI-2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Item
Visit Investigational Product dispensed (double-blind nasal spray)
text
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Visit Investigational Product dispensed
Code List
Visit Investigational Product dispensed (double-blind nasal spray)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
Replacement 1 (if used) (Replacement 1 (if used))
CL Item
Replacement 2 (if used) (Replacement 2 (if used))
CL Item
Replacement 3 (if used) (Replacement 3 (if used))
Date Investigational Product Dispensed
Item
Date Investigational Product Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Weight of Investigational Product when dispensed
Item
Weight of Investigational Product when dispensed
float
C0013227 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
C0043100 (UMLS CUI [1,3])
Date investigational product returned
Item
Date investigational product returned
date
C0013230 (UMLS CUI [1,1])
C2826249 (UMLS CUI [1,2])
Weight of investigational Product when returned
Item
Weight of investigational Product when returned
float
C0304229 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
C0043100 (UMLS CUI [1,3])
Item Group
Investigational Product Replacement Container Numbers
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0559956 (UMLS CUI-3)
C0600091 (UMLS CUI-4)
Item
Replacement Number (if used)
integer
C0559956 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0180098 (UMLS CUI [1,3])
Replacement Number
Code List
Replacement Number (if used)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Investigational Prodcut Container Number
Item
Record the identifying number from the (replacement) investigational product container dispensed (if applicable) during the treatment period.
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
If Treatment Blind was broken during the study, when?
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Treatment Blind was broken during the study, why?
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
If Treatment Blind was broken during the study, why?
CL Item
Medical emergency requiring identification of investigational product for further treatment. (1)
CL Item
other (Z)
Item
If other reason for breaking treatment blind, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Reason blind broken
Code List
If other reason for breaking treatment blind, specify
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