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