ID

41972

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 (2)
  1. 02.03.21 02.03.21 -
  2. 02.03.21 02.03.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

2. März 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

Englisch

Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

1 Formulare  
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Beschreibung

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
12-Lead ECG/ Holter/ Telemetry ECG
Beschreibung

12-Lead ECG/ Holter/ Telemetry ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013801
UMLS CUI-3
C1623258
UMLS CUI-4
C0039451
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
ECG - Heart rate
Beschreibung

ECG - Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
ECG - PR Interval
Beschreibung

ECG - PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
ECG - QRS Duration
Beschreibung

ECG - QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
ms
ECG - Uncorrected QT Interval
Beschreibung

ECG - Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
ms
ECG - QTc Interval
Beschreibung

ECG - QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
ms
ECG - Method of QTc Calculation
Beschreibung

ECG - Method of QTc Calculation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual date/time
Beschreibung

Vital Signs - Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Beschreibung

Vital Signs - Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pulmonary Function Tests
Beschreibung

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Pulmonary Function Tests - Date/time of test
Beschreibung

Pulmonary Function Tests - Date/time of test

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Beschreibung

Pulmonary Function Tests - FEV1 Reading 1 (3 readings)

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Beschreibung

Pulmonary Function Tests - FEV1 Reading 2 (3 readings)

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Beschreibung

Pulmonary Function Tests - FEV1 Reading 3 (3 readings)

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
Local Laboratory - Haematology
Beschreibung

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology - Date and time sample taken
Beschreibung

Haematology - Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0870078
UMLS CUI [3]
C0011008
UMLS CUI [4]
C0040223
Haematology - Has the subject fasted?
Beschreibung

Haematology - Has the subject fasted?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0015663
Local Laboratory - Haematology
Beschreibung

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Beschreibung

Haematology Test

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Haematology - Numeric result
Beschreibung

Haematology - Numeric result

Datentyp

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
Haematology - Character result
Beschreibung

Haematology - Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2350015
Haematology - No result
Beschreibung

Haematology - No result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clincical Chemistry - Date and time sample taken
Beschreibung

Clincical Chemistry - Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0870078
UMLS CUI [3]
C0011008
UMLS CUI [4]
C0040223
Clinical Chemistry - Has subject fasted?
Beschreibung

Clinical Chemistry - Has subject fasted?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0015663
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-6
C0022885
UMLS CUI-7
C0008000
Clinical Chemistry Test
Beschreibung

Clinical Chemistry Test

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Clinical Chemistry - Numeric result
Beschreibung

Clinical Chemistry - Numeric result

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry - Character result
Beschreibung

Clinical Chemistry - Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Clinical Chemistry - No result
Beschreibung

Clinical Chemistry - No result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Urinalysis - Local
Beschreibung

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Urinalysis - Date and time sample taken
Beschreibung

Urinalysis - Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Result of dipstick
Beschreibung

Result of dipstick

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Was sedimentary microscopy performed?
Beschreibung

If yes, provide details on the MICROSCOPY form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis - Local: Dipstick Details
Beschreibung

Urinalysis - Local: Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Dipstick Test
Beschreibung

Dipstick Test

Datentyp

integer

Alias
UMLS CUI [1]
C0430370
Dipstick - Numeric result
Beschreibung

Dipstick - Numeric result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2347373
Dipstick - Character result
Beschreibung

Dipstick - Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2350015
Dipstick - No result
Beschreibung

Dipstick - No result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis - Local: Microscopy Details
Beschreibung

Urinalysis - Local: Microscopy Details

Microscopy - Date and time sample taken
Beschreibung

Microscopy - Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1]
C0430397
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0200345
UMLS CUI [3,1]
C0040223
UMLS CUI [3,2]
C0200345
Microscopy Test
Beschreibung

Microscopy Test

Datentyp

integer

Alias
UMLS CUI [1]
C0430397
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Ähnliche Modelle

Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
12-Lead ECG/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
ECG - Heart rate
Item
ECG - Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
ECG - PR Interval
Item
ECG - PR Interval
integer
C0429087 (UMLS CUI [1])
ECG - QRS Duration
Item
ECG - QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
ECG - Uncorrected QT Interval
Item
ECG - Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
ECG - QTc Interval
Item
ECG - QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
ECG - Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
ECG - Method of QTc Calculation
Code List
ECG - Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Pulmonary Function Tests - Date/time of test
Item
Pulmonary Function Tests - Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 1 (3 readings)
integer
C0748133 (UMLS CUI [1])
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 2 (3 readings)
integer
C0748133 (UMLS CUI [1])
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
Item
Pulmonary Function Tests - FEV1 Reading 3 (3 readings)
integer
C0748133 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Haematology - Date and time sample taken
Item
Haematology - Date and time sample taken
datetime
C0018941 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Haematology - Has the subject fasted?
Item
Haematology - Has the subject fasted?
boolean
C0018941 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Haematology Test
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
Platelets (10)
CL Item
Reticulocyte Count (11)
CL Item
MCV (12)
CL Item
MCH (13)
CL Item
MCHC (14)
Haematology - Numeric result
Item
Haematology - Numeric result
float
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Haematology - Character result
Item
Haematology - Character result
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Haematology - No result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haematology - No result
Code List
Haematology - No result
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Clincical Chemistry - Date and time sample taken
Item
Clincical Chemistry - Date and time sample taken
datetime
C0008000 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Clinical Chemistry - Has subject fasted?
Item
Clinical Chemistry - Has subject fasted?
boolean
C0008000 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-6)
C0008000 (UMLS CUI-7)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinicla Chemistry Test
Code List
Clinical Chemistry Test
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilirubin (3)
CL Item
Glucose (4)
CL Item
GGT (5)
CL Item
Total Protein (6)
CL Item
Albumin (7)
CL Item
Potassium (8)
CL Item
Sodium (9)
CL Item
Chloride (10)
CL Item
Urea (11)
CL Item
Creatinine (12)
CL Item
Uric Acid (13)
CL Item
Alkaline Phosphatase (14)
CL Item
Direct Bilirubin (15)
CL Item
Calcium (16)
Clinical Chemistry - Numeric result
Item
Clinical Chemistry - Numeric result
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry - Character result
Item
Clinical Chemistry - Character result
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Clinical Chemistry - No result
integer
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Clinical Chemistry - No result
Code List
Clinical Chemistry - No result
CL Item
No result (1)
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Urinalysis - Date and time sample taken
Item
Urinalysis - Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
No result (NR)
CL Item
Negative (NEG)
CL Item
Positive (POS)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Item
Dipstick Test
integer
C0430370 (UMLS CUI [1])
Dipstick Test
Code List
Dipstick Test
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Ketones (3)
CL Item
Bilirubin (4)
CL Item
Blood (5)
CL Item
Urobilinogen (6)
CL Item
Leucocytes (7)
CL Item
Specific Gravity (8)
Dipstick - Numeric result
Item
Dipstick - Numeric result
float
C0430370 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Dipstick - Character result
Item
Dipstick - Character result
text
C0430370 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Dipstick - No result
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick - No result
Code List
Dipstick - No result
CL Item
No result (1)
Item Group
Urinalysis - Local: Microscopy Details
Microscopy - Date and time sample taken
Item
Microscopy - Date and time sample taken
datetime
C0430397 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Item
Microscopy Test
integer
C0430397 (UMLS CUI [1])
Microscopy Test
Code List
Microscopy Test
CL Item
White blood cells (1)
CL Item
Red blood cells (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
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