ID
41967
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 (3)
- 22-02-21 22-02-21 -
- 22-02-21 22-02-21 -
- 25-02-21 25-02-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 februari 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
Visit 1, 3, 5 - Randomisation Number; Vital Signs; Nasal Inspection; Challenge Date and Time; Investigational Product
Beschrijving
Randomisation Number (Vsit 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschrijving
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Beschrijving
Vital Signs - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Beschrijving
Start of Challenge - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1264639
Beschrijving
Start of Challenge - Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0871470
Beschrijving
Start of Challenge - Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0428883
Beschrijving
Start of Challenge - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0018810
Beschrijving
Nasal Inspection (Visit 1, 3, 5)
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
Beschrijving
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0805586
- UMLS CUI-2
- C1264639
Beschrijving
Challenge (0 - 6 Hr) - Start date/time of challenge
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0805586
- UMLS CUI [2,2]
- C1301880
Beschrijving
Challenge (0 - 6 Hr) - End time of challenge
Datatype
time
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C1522314
Beschrijving
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
Beschrijving
Investigational Product - Date/time of dose (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Beschrijving
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C0750484
Beschrijving
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beschrijving
If subject did not receive the correct treatment, record reason
Datatype
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])