ID

41978

Description

Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Keywords

Versions (1)
  1. 3/11/21 3/11/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 11, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

English

Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

1 forms  
Total Nasal Symptom Scores
Description

Total Nasal Symptom Scores

Alias
UMLS CUI-1
C3533163
UMLS CUI-2
C0028429
Date and time of assessment
Description

Date and time of assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Nasal blockage
Description

Nasal blockage

Data type

text

Alias
UMLS CUI [1]
C0027429
Rhinorrhea
Description

Rhinorrhea

Data type

text

Alias
UMLS CUI [1]
C1260880
Nasal itching
Description

Nasal itching

Data type

text

Alias
UMLS CUI [1]
C0850060
Sneezing
Description

Sneezing

Data type

text

Alias
UMLS CUI [1]
C0037383
Total Nasal Symptom Scores
Description

Total Nasal Symptom Scores

Data type

text

Alias
UMLS CUI [1,1]
C3533163
UMLS CUI [1,2]
C0028429
VAS
Description

VAS

Alias
UMLS CUI-1
C2732809
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Severity of your nasal congestion symptoms
Description

Severity of your nasal congestion symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0027424
UMLS CUI [1,2]
C0439793
Pharmacogenetic Research Consent
Description

Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

Has informed consent been obtained for PGx-Pharmacogenetic research?

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for PGx-Pharmacogenetic research
Description

Date informed consent obtained for PGx-Pharmacogenetic research

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Description

Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Record date sample taken
Description

Record date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Reason for consent has not been obtained
Description

Reason for consent has not been obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0566251
Specify other reason for consent has not been obtained
Description

Specify other reason for consent has not been obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0566251
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Pharmacogenetic Research Withdrawal of Consent
Description

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Description

Has subject withdrawn consent for PGx research?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Date informed consent withdrawn
Description

Date informed consent withdrawn

Data type

date

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

Has a request been made for sample destruction?

Data type

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
Check reason for sample destruction
Description

Check reason for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Specify other reason for sample destruction
Description

Specify other reason for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Back to the top of the page

Similar models

Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Total Nasal Symptom Scores
C3533163 (UMLS CUI-1)
C0028429 (UMLS CUI-2)
Date and time of assessment
Item
Date and time of assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Nasal blockage
Item
Nasal blockage
text
C0027429 (UMLS CUI [1])
Rhinorrhea
Item
Rhinorrhea
text
C1260880 (UMLS CUI [1])
Nasal itching
Item
Nasal itching
text
C0850060 (UMLS CUI [1])
Sneezing
Item
Sneezing
text
C0037383 (UMLS CUI [1])
Total Nasal Symptom Scores
Item
Total Nasal Symptom Scores
text
C3533163 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
Item Group
VAS
C2732809 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Severity of your nasal congestion symptoms
Item
Severity of your nasal congestion symptoms
text
C0027424 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Item Group
Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Record date sample taken
Item
Record date sample taken
date
C1302413 (UMLS CUI [1])
Item
Reason for consent has not been obtained
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Reason for consent has not been obtained
Code List
Reason for consent has not been obtained
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
Specify other reason for consent has not been obtained
Item
Specify other reason for consent has not been obtained
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Date informed consent withdrawn
Item
Date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
Check reason for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Check reason for sample destruction
Code List
Check reason for sample destruction
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
Specify other reason for sample destruction
Item
Specify other reason for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial