ID
41967
Beschreibung
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
Stichworte
Versionen (3)
- 22.02.21 22.02.21 -
- 22.02.21 22.02.21 -
- 25.02.21 25.02.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
25. Februar 2021
DOI
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Lizenz
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
Beschreibung
Randomisation Number (Vsit 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Vital Signs - Challenge Date and Time (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C1264639
Beschreibung
Vital Signs - Start of Challenge (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0805586
- UMLS CUI-3
- C0808070
Beschreibung
Start of Challenge - Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1264639
Beschreibung
Start of Challenge - Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0871470
Beschreibung
Start of Challenge - Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0428883
Beschreibung
Start of Challenge - Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0018810
Beschreibung
Nasal Inspection (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0558826
Beschreibung
Challenge date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1272683
- UMLS CUI [1,2]
- C1264639
Beschreibung
Date/time of Assessment
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschreibung
Left Nostril Colour
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Beschreibung
Right Nostril colour
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Beschreibung
Left nostril concha media turbinate Swelling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beschreibung
Left nostril concha inferior turbinate swelling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beschreibung
Right nostril concha media turbinate swelling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beschreibung
Right nostril concha inferior turbinate swelling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beschreibung
Left nostril secretions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Beschreibung
Right nostril secretions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Beschreibung
Nasal Infection
Datentyp
text
Alias
- UMLS CUI [1]
- C0555970
Beschreibung
Post Nasal Drip
Datentyp
text
Alias
- UMLS CUI [1]
- C0032781
Beschreibung
Crusting
Datentyp
text
Alias
- UMLS CUI [1]
- C0205204
Beschreibung
Signs of Bleeding
Datentyp
text
Alias
- UMLS CUI [1]
- C0019080
Beschreibung
Specify signs of bleeding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C2348235
Beschreibung
Challenge Date and Time - Challenge (0 - 6 Hr) (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0805586
- UMLS CUI-2
- C1264639
Beschreibung
Challenge (0 - 6 Hr) - Start date/time of challenge
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0805586
- UMLS CUI [2,2]
- C1301880
Beschreibung
Challenge (0 - 6 Hr) - End time of challenge
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0805586
- UMLS CUI [1,2]
- C1522314
Beschreibung
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
Beschreibung
Investigational Product - Date/time of dose (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Beschreibung
Investigational Product - Treatment Confirmation (Visit 1, 3, 5)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C0750484
Beschreibung
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beschreibung
If subject did not receive the correct treatment, record reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Ähnliche Modelle
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])