ID
41977
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 (1)
- 11-03-21 11-03-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 maart 2021
DOI
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Licentie
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
Beschrijving
12-Lead ECG/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
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 - PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
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
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
A. Rhythm
Datatype
text
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Other abnormal rhythm, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschrijving
B. P-Wave Morphology
Datatype
text
Alias
- UMLS CUI [1]
- C2216025
Beschrijving
Other morphology, enter comment
Datatype
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
Beschrijving
C. Conduction
Datatype
text
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
Other conduction, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C0205394
Beschrijving
D. Myocardial Infarction
Datatype
text
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Other myocardial infarction, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
E. Depolarisation/Repolarisation (QRS-T)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
Beschrijving
Other depolarisation/repolarisation, enter comment
Datatype
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
Beschrijving
Other abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other abnormalities, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
Vital Signs
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
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
Alias
- UMLS CUI-1
- C0022885
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
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
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Beschrijving
Microscopy Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Microscopy - Numeric result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2347373
Beschrijving
Microscopy - Character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2350015
Beschrijving
Microscopy - No result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0456984
Beschrijving
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Beschrijving
Date/time of test
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C1264639
Beschrijving
FEV1 - 1 (3 readings)
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
FEV1 - 2 (3 readings)
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
FEV1 - 3 (3 readings)
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
Nasal Airflow Resistance
Alias
- UMLS CUI-1
- C0028429
- UMLS CUI-2
- C0199498
Beschrijving
Date and time of assessment
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschrijving
Nasal Airflow Resistance - Left Nostril (150Pa)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720438
Beschrijving
Nasal Airflow Resistance - Right Nostril (150Pa)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0028429
- UMLS CUI [1,2]
- C0199498
- UMLS CUI [1,3]
- C1720679
Beschrijving
Nasal Inspection
Alias
- UMLS CUI-1
- C0558826
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
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])