ID
35636
Description
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
Keywords
Versions (1)
- 3/13/19 3/13/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 13, 2019
DOI
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License
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
Period 2
- StudyEvent: ODM
Description
Investigational Product (Dose)
Description
Vital Signs (Dosing)
Description
Dose Time
Data type
integer
Description
Blood Pressure - Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Temperature (Dosing)
Description
Dose Time
Data type
integer
Description
t° Reading1
Data type
float
Measurement units
- °C
Description
t° Reading2
Data type
float
Measurement units
- °C
Description
t° Reading3
Data type
float
Measurement units
- °C
Description
Hematology (Dosing)
Description
Dose Time
Data type
integer
Description
Fasting
Data type
boolean
Description
WBC
Data type
text
Alias
- UMLS CUI [1]
- C0023508
Description
RBC
Data type
text
Alias
- UMLS CUI [1]
- C0014772
Description
Hemoglobin measurement
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0518015
Description
Neutrophils
Data type
float
Measurement units
- 1000/μl
Alias
- UMLS CUI [1]
- C0200633
Description
Lymphocytes
Data type
text
Alias
- UMLS CUI [1]
- C0200635
Description
Monocytes
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0200638
Description
Basophils
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0200641
Description
Platelets
Data type
float
Measurement units
- 10^9/ L
Alias
- UMLS CUI [1]
- C0005821
Description
Reticulocyte count
Data type
float
Alias
- UMLS CUI [1]
- C0206161
Description
MCV
Data type
integer
Measurement units
- fL
Description
MCH
Data type
float
Measurement units
- pg
Alias
- UMLS CUI [1]
- C0369183
Description
Mean corpuscular hemoglobin concentration determination
Data type
float
Alias
- UMLS CUI [1]
- C0474535
Description
Test Date
Data type
date
Description
Clinical Chemistry
Description
Dose Time
Data type
text
Description
Fasting
Data type
boolean
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
Chemistry, Clinical; Aspartate aminotransferase measurement
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0201899
Description
Total Bilirubin
Data type
text
Alias
- UMLS CUI [1]
- C0201913
Description
Glucose
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0202042
Description
Chemistry, Clinical; Gamma glutamyl transferase measurement
Data type
float
Alias
- UMLS CUI [1]
- C0202035
Description
Chemistry, Clinical; Total Protein measurement
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0555903
Description
Albumin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0201838
Description
Potassium
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Description
Sodium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0337443
Description
Chloride
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0201952
Description
Chemistry, Clinical, Creatinine measurement
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0201975
Description
Chemistry, Clinical; Uric acid
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0041980
Description
Alkaline Phosphatase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
BUN
Data type
float
Measurement units
- mg/dL
Description
Cholesterol
Data type
float
Alias
- UMLS CUI [1]
- C1445957
Description
Carbon dioxide total measurement; Result; Data Type -Character
Data type
text
Alias
- UMLS CUI [1,1]
- C0860709
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Description
Triglycerides
Data type
float
Alias
- UMLS CUI [1]
- C0202236
Description
LDH
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
Calcium
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0201925
Description
Plasma ACTH
Data type
text
Description
Serum Progesterone
Data type
text
Description
Serum cortisol
Data type
text
Measurement units
- g/dL
Description
Serum testosterone
Data type
text
Description
Treatment ID=1339
Data type
text
Measurement units
- nmol/l
Alias
- UMLS CUI [1]
- C0202218
Description
Electrocardiogram
Description
Dose Time
Data type
integer
Description
Time of ECG
Data type
time
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Electrocardiogram: P-R interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS complex duration (observable entity)
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
QT interval - finding
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
qtc interval; Evaluation Method
Data type
integer
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Description
Peak Nasal Inspiratory Flow Rate
Description
Total Symptom Score
Description
Dose Time
Data type
integer
Description
Nasal congestion score
Data type
integer
Description
Rhinorrhoea score
Data type
integer
Description
Lacrimation score
Data type
integer
Description
Burning/pain score
Data type
integer
Description
Total Symptom Score
Data type
text
Description
Visual Analogue Scale
Description
Dose Time
Data type
integer
Description
Nasal congestion VAS score
Data type
integer
Measurement units
- mm
Description
Rhinorrhoea VAS Score
Data type
text
Measurement units
- mm
Description
Lacrimation VAS score
Data type
integer
Measurement units
- mm
Description
Burning/pain VAS score
Data type
integer
Measurement units
- mm
Description
Nostril Secretions
Description
Dose Time
Data type
integer
Description
Actual start time
Data type
time
Description
Actual end time
Data type
time
Description
Acciwik Left Nostril secretion weight
Data type
float
Measurement units
- mg
Description
Tissue Left Nostril secretion weight
Data type
float
Measurement units
- mg
Description
Acciwik Right Nostril secretion weight
Data type
float
Measurement units
- mg
Description
Tissue Right Nostril secretion weight
Data type
float
Measurement units
- mg
Description
Pharmacokinetics - Blood
Description
Dose Time
Data type
integer
Description
Actual time
Data type
time
Similar models
Period 2
- StudyEvent: ODM
C0201899 (UMLS CUI [1,2])
C0555903 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
C0041980 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])