ID
41967
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 (3)
- 2021-02-22 2021-02-22 -
- 2021-02-22 2021-02-22 -
- 2021-02-25 2021-02-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 februari 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
Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product
Beskrivning
Randomisation Number (Vsit 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beskrivning
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Beskrivning
Vital Signs - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Beskrivning
Start of Challenge - Actual date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1264639
Beskrivning
Start of Challenge - Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0871470
Beskrivning
Start of Challenge - Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0428883
Beskrivning
Start of Challenge - Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0018810
Beskrivning
Nasal Inspection (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0558826
Beskrivning
Challenge date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
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
Beskrivning
Signs of Bleeding
Datatyp
text
Alias
- UMLS CUI [1]
- C0019080
Beskrivning
Specify signs of bleeding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C2348235
Beskrivning
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0805586
- UMLS CUI-2
- C1264639
Beskrivning
Challenge (0 - 6 Hr) - Start date/time of challenge
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0805586
- UMLS CUI [2,2]
- C1301880
Beskrivning
Challenge (0 - 6 Hr) - End time of challenge
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C1522314
Beskrivning
Investigational Product (Dose) - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0805586
- UMLS CUI-4
- C1264639
Beskrivning
Investigational Product - Date/time of dose (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Beskrivning
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C0750484
Beskrivning
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beskrivning
If subject did not receive the correct treatment, record reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Similar models
Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product
C2985720 (UMLS CUI [2])
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0805586 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0805586 (UMLS CUI-2)
C0808070 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
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])
C1264639 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1522314 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C0805586 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
C0678766 (UMLS CUI [1,2])
C0805586 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C0750484 (UMLS CUI-3)
C0087111 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])