Informações:
Falhas:
ID
35635
Descrição
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
Palavras-chave
Versões (1)
- 13/03/2019 13/03/2019 -
Titular dos direitos
GSK group of companies
Transferido a
13 de março de 2019
DOI
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Licença
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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Actual Date / Time
Item
Actual Date and Time
datetime
Systolic Blood Pressure
Item
Systolic Blood pressure (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood pressure (mmHg)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Subject Randomisation
Item
Was the subject able to be randomised?
boolean
Randomisation Number
Item
Randomisation Number
integer
Dose Date and Time
Item
Date and Time of Dose
datetime
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treament which the subject was assigned to) during this dosing interval?
boolean
Incorrect Treatment Reasons
Item
Record reasons for incorrect treatment
text
CL Item
Pre-Dose (1)
CL Item
20 min (2)
CL Item
40 min (3)
CL Item
60 min (4)
CL Item
80 min (5)
CL Item
100 min (6)
CL Item
120 min (7)
CL Item
3 hrs (8)
CL Item
4 hrs (9)
CL Item
5 hrs (10)
CL Item
6 hrs (11)
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
integer
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
integer
Heart Rate
Item
Heart Rate
integer
CL Item
Pre-Dose (1)
CL Item
20 min (2)
CL Item
40 min (3)
CL Item
60 min (4)
CL Item
80 min (5)
CL Item
100 min (6)
CL Item
120 min (7)
CL Item
3 hrs (8)
CL Item
4 hrs (9)
CL Item
5 hrs (10)
CL Item
6 hrs (11)
t° Reading1
Item
t° Reading1
float
t° Reading2
Item
t° Reading2
float
t° Reading3
Item
t° Reading3
float
CL Item
Pre-Dose (1)
CL Item
6 hrs (2)
Fasting
Item
Has the subject fasted?
boolean
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
RBC
Item
RBC
text
C0014772 (UMLS CUI [1])
Hemoglobin measurement
Item
Haemoglobin
float
C0518015 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
text
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Reticulocyte count
Item
Reticulocyte count
float
C0206161 (UMLS CUI [1])
MCV
Item
MCV
integer
MCH
Item
MCH
float
C0369183 (UMLS CUI [1])
Mean corpuscular hemoglobin concentration determination
Item
MCHC
float
C0474535 (UMLS CUI [1])
Test Date
Item
Date of test
date
CL Item
Pre-Dose (1)
CL Item
6 hrs (2)
Fasting
Item
Has the subject fasted?
boolean
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Chemistry, Clinical; Aspartate aminotransferase measurement
Item
AST
float
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Chemistry, Clinical; Gamma glutamyl transferase measurement
Item
GGT
float
C0202035 (UMLS CUI [1])
Chemistry, Clinical; Total Protein measurement
Item
Total Protein
float
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C0555903 (UMLS CUI [1,2])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Chemistry, Clinical, Creatinine measurement
Item
Creatinine
float
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
Chemistry, Clinical; Uric acid
Item
Uric acid
float
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
C0041980 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
BUN
Item
[BUN] BUN
float
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Carbon dioxide total measurement; Result; Data Type -Character
Item
Total CO2 - Character result
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
Triglycerides
float
C0202236 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase (LDH)
float
C0202113 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Plasma ACTH
Item
Plasma ACTH
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Serum cortisol
Item
text
Serum testosterone
Item
Serum testosterone
text
SHBG
Item
text
C0202218 (UMLS CUI [1])
CL Item
Pre-Dose (1)
CL Item
60 min (2)
CL Item
120 min (3)
CL Item
3 hrs (4)
CL Item
4 hrs (5)
CL Item
5 hrs (6)
CL Item
6 hrs (7)
Time of ECG
Item
Time of ECG
time
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0489625 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
CL Item
55 min (1)
CL Item
75 min (2)
CL Item
95 min (3)
CL Item
115 min (4)
PNIF (reading 1)
Item
PNIF (reading 1)
integer
PNIF (reading 2)
Item
PNIF (reading 2)
integer
PNIF reading 3
Item
PNIF reading 3
integer
CL Item
41 min (1)
CL Item
45 min (2)
CL Item
50 min (3)
CL Item
61 min (4)
CL Item
65 min (5)
CL Item
70 min (6)
CL Item
81 min (7)
CL Item
85 min (8)
CL Item
90 min (9)
CL Item
101 min (10)
CL Item
105 min (11)
CL Item
110 min (12)
Nasal congestion score
Item
Nasal congestion score
integer
Rhinorrhoea score
Item
Rhinorrhoea score
integer
Lacrimation score
Item
Lacrimation score
integer
Burning/pain score
Item
Burning/pain score
integer
Total Symptom Score
Item
Total Symptom Score
text
CL Item
41 min (1)
CL Item
45 min (2)
CL Item
50 min (3)
CL Item
61 min (4)
CL Item
65 min (5)
CL Item
70 min (6)
CL Item
81 min (7)
CL Item
85 min (8)
CL Item
90 min (9)
CL Item
101 min (10)
CL Item
105 min (11)
CL Item
110 min (12)
Nasal congestion VAS score
Item
Nasal congestion VAS score
integer
Rhinorrhoea VAS Score
Item
Rhinorrhoea VAS Score
text
Lacrimation VAS score
Item
Lacrimation VAS score
integer
Burning/pain VAS score
Item
Burning/pain VAS score
integer
CL Item
41-43 min (1)
CL Item
45-47 min (2)
CL Item
49-51 min (3)
CL Item
61-63 min (5)
CL Item
65-67 min (6)
CL Item
69-71 min (7)
CL Item
81-83 min (8)
CL Item
85-87 min (9)
CL Item
89-91 min (10)
CL Item
101-103 min (11)
CL Item
105-107 min (12)
CL Item
109-111 min (13)
Actual start time
Item
Actual start time
time
Actual end time
Item
Actual end time
time
Acciwik Left Nostril secretion weight
Item
Acciwik Left Nostril secretion weight
float
Tissue Left Nostril secretion weight
Item
Tissue Left Nostril secretion weight
float
Acciwik Right Nostril secretion weight
Item
Acciwik Right Nostril secretion weight
float
Tissue Right Nostril secretion weight
Item
Tissue Right Nostril secretion weight
float