Information:
Fel:
ID
35635
Beskrivning
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis
Nyckelord
Versioner (1)
- 2019-03-13 2019-03-13 -
Rättsinnehavare
GSK group of companies
Uppladdad den
13 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
Similar models
Period 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Visit Date
Item
date
Subject Number
Item
integer
Actual Date / Time
Item
datetime
Systolic Blood Pressure
Item
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
integer
C0018810 (UMLS CUI [1])
Subject Randomisation
Item
boolean
Randomisation Number
Item
integer
Dose Date and Time
Item
datetime
Treatment Confirmation
Item
boolean
Incorrect Treatment Reasons
Item
text
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(11)
Blood Pressure - Systolic
Item
integer
Blood Pressure - Diastolic
Item
integer
Heart Rate
Item
integer
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(11)
t° Reading1
Item
float
t° Reading2
Item
float
t° Reading3
Item
float
CL Item
(1)
CL Item
(2)
Fasting
Item
boolean
WBC
Item
text
C0023508 (UMLS CUI [1])
RBC
Item
text
C0014772 (UMLS CUI [1])
Hemoglobin measurement
Item
float
C0518015 (UMLS CUI [1])
Neutrophils
Item
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
text
C0200635 (UMLS CUI [1])
Monocytes
Item
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
float
C0200638 (UMLS CUI [1])
Basophils
Item
float
C0200641 (UMLS CUI [1])
Platelets
Item
float
C0005821 (UMLS CUI [1])
Reticulocyte count
Item
float
C0206161 (UMLS CUI [1])
MCV
Item
integer
MCH
Item
float
C0369183 (UMLS CUI [1])
Mean corpuscular hemoglobin concentration determination
Item
float
C0474535 (UMLS CUI [1])
Test Date
Item
date
CL Item
(1)
CL Item
(2)
Fasting
Item
boolean
ALT
Item
float
C0201836 (UMLS CUI [1])
Chemistry, Clinical; Aspartate aminotransferase measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
Total Bilirubin
Item
text
C0201913 (UMLS CUI [1])
Glucose
Item
float
C0202042 (UMLS CUI [1])
Chemistry, Clinical; Gamma glutamyl transferase measurement
Item
float
C0202035 (UMLS CUI [1])
Chemistry, Clinical; Total Protein measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C0555903 (UMLS CUI [1,2])
Albumin
Item
float
C0201838 (UMLS CUI [1])
Potassium
Item
float
C0202194 (UMLS CUI [1])
Sodium
Item
float
C0337443 (UMLS CUI [1])
Chloride
Item
float
C0201952 (UMLS CUI [1])
Chemistry, Clinical, Creatinine measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
Chemistry, Clinical; Uric acid
Item
float
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
C0041980 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
float
C0201850 (UMLS CUI [1])
BUN
Item
float
Cholesterol
Item
float
C1445957 (UMLS CUI [1])
Carbon dioxide total measurement; Result; Data Type -Character
Item
text
C0860709 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Triglycerides
Item
float
C0202236 (UMLS CUI [1])
LDH
Item
float
C0202113 (UMLS CUI [1])
Calcium
Item
float
C0201925 (UMLS CUI [1])
Plasma ACTH
Item
text
CL Item
(1)
CL Item
(2)
CL Item
(3)
Serum cortisol
Item
text
Serum testosterone
Item
text
SHBG
Item
SHBG
text
C0202218 (UMLS CUI [1])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
Time of ECG
Item
time
Heart rate
Item
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
float
C1287082 (UMLS CUI [1])
CL Item
(1)
CL Item
(2)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
PNIF (reading 1)
Item
integer
PNIF (reading 2)
Item
integer
PNIF reading 3
Item
integer
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(11)
CL Item
(12)
Nasal congestion score
Item
integer
Rhinorrhoea score
Item
integer
Lacrimation score
Item
integer
Burning/pain score
Item
integer
Total Symptom Score
Item
text
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(11)
CL Item
(12)
Nasal congestion VAS score
Item
integer
Rhinorrhoea VAS Score
Item
text
Lacrimation VAS score
Item
integer
Burning/pain VAS score
Item
integer
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(11)
CL Item
(12)
CL Item
(13)
Actual start time
Item
time
Actual end time
Item
time
Acciwik Left Nostril secretion weight
Item
float
Tissue Left Nostril secretion weight
Item
float
Acciwik Right Nostril secretion weight
Item
float
Tissue Right Nostril secretion weight
Item
float