ID
41977
Beskrivning
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
Nyckelord
Versioner (1)
- 2021-03-11 2021-03-11 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 mars 2021
DOI
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Licens
Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356
Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection
Beskrivning
12-Lead ECG/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
ECG - Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beskrivning
ECG - PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
ECG - QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beskrivning
ECG - Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beskrivning
ECG - QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beskrivning
ECG - Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
A. Rhythm
Datatyp
text
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Other abnormal rhythm, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beskrivning
B. P-Wave Morphology
Datatyp
text
Alias
- UMLS CUI [1]
- C2216025
Beskrivning
Other morphology, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0430456
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0947611
- UMLS CUI [2,2]
- C0205394
Beskrivning
C. Conduction
Datatyp
text
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Other conduction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C0205394
Beskrivning
D. Myocardial Infarction
Datatyp
text
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Other myocardial infarction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
E. Depolarisation/Repolarisation (QRS-T)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
Beskrivning
Other depolarisation/repolarisation, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
- UMLS CUI [3,1]
- C0205394
- UMLS CUI [3,2]
- C0947611
Beskrivning
Other abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other abnormalities, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital Signs - Actual date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beskrivning
Systolic Blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Vital Signs - Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beskrivning
Local Laboratory
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Haematology - Date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1]
- C0018941
- UMLS CUI [2]
- C0870078
- UMLS CUI [3]
- C0011008
- UMLS CUI [4]
- C0040223
Beskrivning
Haematology - Has the subject fasted?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0015663
Beskrivning
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beskrivning
Haematology Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Haematology - Numeric result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Beskrivning
Haematology - Character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Beskrivning
Haematology - No result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beskrivning
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beskrivning
Clinical Chemistry Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0525044
Beskrivning
Clinical Chemistry - Numeric result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Beskrivning
Clinical Chemistry - Character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Beskrivning
Clinical Chemistry - No result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beskrivning
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beskrivning
Urinalysis - Date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beskrivning
Result of dipstick
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beskrivning
If yes, provide details on the MICROSCOPY form
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beskrivning
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Beskrivning
Dipstick Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430370
Beskrivning
Dipstick - Numeric result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2347373
Beskrivning
Dipstick - Character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C2350015
Beskrivning
Dipstick - No result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beskrivning
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Beskrivning
Microscopy Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430397
Beskrivning
Microscopy - Numeric result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2347373
Beskrivning
Microscopy - Character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2350015
Beskrivning
Microscopy - No result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0456984
Beskrivning
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Beskrivning
Date/time of test
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C1264639
Beskrivning
FEV1 - 1 (3 readings)
Datatyp
integer
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0748133
Beskrivning
FEV1 - 2 (3 readings)
Datatyp
integer
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0748133
Beskrivning
FEV1 - 3 (3 readings)
Datatyp
integer
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0748133
Beskrivning
Nasal Airflow Resistance
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
Beskrivning
Date and time of assessment
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beskrivning
Nasal Airflow Resistance - Left Nostril (150Pa)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720438
Beskrivning
Nasal Airflow Resistance - Right Nostril (150Pa)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720679
Beskrivning
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
Beskrivning
Date/time of Assessment
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beskrivning
Left Nostril Colour
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Beskrivning
Right Nostril colour
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Beskrivning
Left nostril concha media turbinate Swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beskrivning
Left nostril concha inferior turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beskrivning
Right nostril concha media turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beskrivning
Right nostril concha inferior turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beskrivning
Left nostril secretions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Beskrivning
Right nostril secretions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Beskrivning
Nasal Infection
Datatyp
text
Alias
- UMLS CUI [1]
- C0555970
Beskrivning
Post Nasal Drip
Datatyp
text
Alias
- UMLS CUI [1]
- C0032781
Beskrivning
Crusting
Datatyp
text
Alias
- UMLS CUI [1]
- C0205204
Similar models
Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1516698 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0439148 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
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])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C0947611 (UMLS CUI [3,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
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)
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])
C0042014 (UMLS CUI-2)
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0199498 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
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])