ID
41937
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 (2)
- 2/16/21 2/16/21 -
- 3/2/21 3/2/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 16, 2021
DOI
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License
Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356
Screening - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection
Description
Inform Enrolment
Alias
- UMLS CUI-1
- C1552002
- UMLS CUI-2
- C4041024
Description
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Age in years
Data type
integer
Alias
- UMLS CUI [1]
- C0001779
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geographic ancestry
Data type
integer
Alias
- UMLS CUI [1]
- C3841890
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
ECG Measurement
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
ECG - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
ECG - QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
ECG - Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
ECG - QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
ECG - Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Vital Signs - Measurement 1
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Actual date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Description
Vital Signs - Measurement 2 and 3
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0518766
Description
Vital Signs - Actual time
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Haematology - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Description
Haematology - Has the subject fasted?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0015663
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Description
Haematology - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Clincical Chemistry - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1]
- C0008000
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Description
Clinical Chemistry - Has subject fasted?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0015663
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-6
- C0022885
- UMLS CUI-7
- C0008000
Description
Clinical Chemistry Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Clinical Chemistry - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Clinical Chemistry - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Result of dipstick
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
If yes, provide details on the MICROSCOPY form
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Description
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Description
Dipstick Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430370
Description
Dipstick - Numeric result
Data type
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Description
Dipstick - Character result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2350015
Description
Dipstick - No result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Urinalysis - Local: Microscopy Details
Description
Microscopy - Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1]
- C0430397
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0200345
- UMLS CUI [3,1]
- C0040223
- UMLS CUI [3,2]
- C0200345
Description
Microscopy Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
Description
Challenge date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
Description
Date/time of Assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate Swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Left nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Left nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal Infection
Data type
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Data type
text
Alias
- UMLS CUI [1]
- C0032781
Description
Crusting
Data type
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Data type
text
Alias
- UMLS CUI [1]
- C0019080
Description
Specify signs of bleeding
Data type
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C2348235
Similar models
Screening - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection
C2986440 (UMLS CUI [1,2])
C2985720 (UMLS CUI [2])
C0018810 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
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C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
C0015663 (UMLS CUI [1,2])
C0008000 (UMLS CUI-7)
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C0587081 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
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C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])