ID
41937
Beschrijving
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
Trefwoorden
Versies (2)
- 16-02-21 16-02-21 -
- 02-03-21 02-03-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 februari 2021
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Inform Enrolment
Alias
- UMLS CUI-1
- C1552002
- UMLS CUI-2
- C4041024
Beschrijving
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Age in years
Datatype
integer
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Geographic ancestry
Datatype
integer
Alias
- UMLS CUI [1]
- C3841890
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
ECG Measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
ECG - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beschrijving
ECG - QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschrijving
ECG - Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschrijving
ECG - QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschrijving
ECG - Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Vital Signs - Measurement 1
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body mass index
Datatype
float
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
Vital Signs - Measurement 2 and 3
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs - Measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
Vital Signs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Haematology - Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Beschrijving
Haematology - Has the subject fasted?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0015663
Beschrijving
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Haematology Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Haematology - Numeric result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Beschrijving
Haematology - Character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Beschrijving
Haematology - No result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beschrijving
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschrijving
Clincical Chemistry - Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1]
- C0008000
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Beschrijving
Clinical Chemistry - Has subject fasted?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0015663
Beschrijving
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-6
- C0022885
- UMLS CUI-7
- C0008000
Beschrijving
Clinical Chemistry Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
Clinical Chemistry - Numeric result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beschrijving
Clinical Chemistry - Character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beschrijving
Clinical Chemistry - No result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beschrijving
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Urinalysis - Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beschrijving
Result of dipstick
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
If yes, provide details on the MICROSCOPY form
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beschrijving
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beschrijving
Dipstick Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430370
Beschrijving
Dipstick - Numeric result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Beschrijving
Dipstick - Character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2350015
Beschrijving
Dipstick - No result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Urinalysis - Local: Microscopy Details
Beschrijving
Microscopy - Date and time sample taken
Datatype
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
Beschrijving
Microscopy Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
Beschrijving
Challenge date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
Beschrijving
Date/time of Assessment
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschrijving
Left Nostril Colour
Datatype
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Beschrijving
Right Nostril colour
Datatype
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Beschrijving
Left nostril concha media turbinate Swelling
Datatype
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beschrijving
Left nostril concha inferior turbinate swelling
Datatype
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beschrijving
Right nostril concha media turbinate swelling
Datatype
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beschrijving
Right nostril concha inferior turbinate swelling
Datatype
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beschrijving
Left nostril secretions
Datatype
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Beschrijving
Right nostril secretions
Datatype
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Beschrijving
Nasal Infection
Datatype
text
Alias
- UMLS CUI [1]
- C0555970
Beschrijving
Post Nasal Drip
Datatype
text
Alias
- UMLS CUI [1]
- C0032781
Beschrijving
Crusting
Datatype
text
Alias
- UMLS CUI [1]
- C0205204
Beschrijving
Signs of Bleeding
Datatype
text
Alias
- UMLS CUI [1]
- C0019080
Beschrijving
Specify signs of bleeding
Datatype
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])