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ID
41971
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)
- 16.02.21 16.02.21 -
- 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
Screening - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection
Ähnliche Modelle
Screening - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age in years
Item
Age in years
integer
C0001779 (UMLS CUI [1])
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
C2985720 (UMLS CUI [2])
Age in years
Item
Age in years
integer
C0001779 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/ African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - South East Asian Heritage (5)
CL Item
Native Hawaiian or Other Pacific Islander (6)
CL Item
White - Arabic/North African Hertiage (7)
CL Item
White - White/Caucasian/ European Heritage (8)
CL Item
Measurement 1 (1)
CL Item
Measurement 2 (2)
CL Item
Measurement 3 (3)
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])
C0018810 (UMLS CUI [1,2])
ECG - QRS Duration
Item
ECG - QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
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])
C1287082 (UMLS CUI [1,2])
ECG - QTc Interval
Item
ECG - QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
Item
ECG - Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
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])
C0018810 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 2 and 3
C0518766 (UMLS CUI-1)
CL Item
Measurement 2 (1)
CL Item
Measurement 3 (2)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
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])
C0018810 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
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])
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])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
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])
C2347373 (UMLS CUI [1,2])
Haematology - Character result
Item
Haematology - Character result
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
Item
Haematology - No result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
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])
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])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-6)
C0008000 (UMLS CUI-7)
C0008000 (UMLS CUI-7)
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])
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])
C2350015 (UMLS CUI [1,2])
Item
Clinical Chemistry - No result
integer
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
No result (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])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
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])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
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])
C2347373 (UMLS CUI [1,2])
Dipstick - Character result
Item
Dipstick - Character result
text
C0430370 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
Item
Dipstick - No result
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
No result (1)
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])
C0011008 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
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)
Challenge date/time
Item
Challenge date/time
datetime
C1272683 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/time of Assessment
Item
Date/time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Item
Left Nostril Colour
text
C0475705 (UMLS CUI [1,1])
C1720438 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
CL Item
Normal (N)
CL Item
Abnormal; Specify colour (A)
CL Item
Red (R)
CL Item
Blue (B)
CL Item
White (W)
Item
Right Nostril colour
text
C0475705 (UMLS CUI [1,1])
C1720679 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
CL Item
Normal (N)
CL Item
Abnormal (A)
CL Item
Red (R)
CL Item
Blue (B)
CL Item
White (W)
Item
Left nostril concha media turbinate Swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Left nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (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])
Code List
Left nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha media turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Code List
Right nostril concha media turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (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])
Code List
Right nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Left nostril secretions
text
C1720438 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
Item
Right nostril secretions
text
C1720679 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
CL Item
No infection (N)
CL Item
Viral infection (V)
CL Item
Bacterial infection (B)
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
CL Item
No (N)
CL Item
Yes; Please specify (Y)
Specify signs of bleeding
Item
Specify signs of bleeding
text
C0019080 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])