ID
41971
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
Mots-clés
Versions (2)
- 16/02/2021 16/02/2021 -
- 02/03/2021 02/03/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
2 mars 2021
DOI
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Licence
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0001779
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geographic ancestry
Type de données
integer
Alias
- UMLS CUI [1]
- C3841890
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
ECG Measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Date and Time of ECG
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
ECG - Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
ECG - QRS Duration
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
ECG - Uncorrected QT Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
ECG - QTc Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
ECG - Method of QTc Calculation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Vital Signs - Measurement 1
Alias
- UMLS CUI-1
- C0518766
Description
Vital Signs - Actual date/time
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Description
Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Type de données
float
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs - Heart rate
Type de données
integer
Unités de mesure
- 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
Type de données
integer
Alias
- UMLS CUI [1]
- C0518766
Description
Vital Signs - Actual time
Type de données
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Vital Signs - Heart rate
Type de données
integer
Unités de mesure
- 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
Type de données
datetime
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Description
Haematology - Has the subject fasted?
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology - Numeric result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology - Character result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Description
Haematology - No result
Type de données
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
Type de données
datetime
Alias
- UMLS CUI [1]
- C0008000
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Description
Clinical Chemistry - Has subject fasted?
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Clinical Chemistry - Numeric result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry - Character result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Clinical Chemistry - No result
Type de données
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
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Result of dipstick
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
If yes, provide details on the MICROSCOPY form
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0430370
Description
Dipstick - Numeric result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Description
Dipstick - Character result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2350015
Description
Dipstick - No result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Urinalysis - Local: Microscopy Details
Description
Microscopy - Date and time sample taken
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
Description
Challenge date/time
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
Description
Date/time of Assessment
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Type de données
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril colour
Type de données
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate Swelling
Type de données
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
Type de données
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
Type de données
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
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Type de données
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal Infection
Type de données
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Type de données
text
Alias
- UMLS CUI [1]
- C0032781
Description
Crusting
Type de données
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Type de données
text
Alias
- UMLS CUI [1]
- C0019080
Description
Specify signs of bleeding
Type de données
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])
C2911685 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
C0015663 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
C0015663 (UMLS CUI [1,2])
C0008000 (UMLS CUI-7)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C2700128 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
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])