Informatie:
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ID
38652
Beschrijving
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis
Trefwoorden
Versies (1)
- 29-10-19 29-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 oktober 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
Similar models
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all 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)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
Record clinically significant abnormalities - A. Rhythm
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate > 100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate>100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate<=100 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate>100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idiventricular rhythm (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A32)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial Pacemaker (A16)
CL Item
Other abnormal thythm, enter comment (A99)
If other abnormal rhythm, enter comment
Item
If other abnormal rhythm, enter comment
text
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Record clinically significant abnormalities - B. P-Wave Morphology
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
If other P-Wave Morphology, enter comment
Item
If other P-Wave Morphology, enter comment
text
C2216025 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - C. Conduction
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - C. Conduction
CL Item
First degree AV block (PR interval > 200msec) (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS > 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
Prolonged QT interval (C19)
CL Item
QT/QTc prolongation > 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
If other conduction, enter comment
Item
If other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - D. Myocardial infarction
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - D. Myocardial infarction
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
If other myocardial infarction, enter comment.
Item
If other myocardial infarction, enter comment.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
Code List
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisation/repolarisation, enter comment (D99)
If other depololarisation/repolarisation, enter comment
Item
If other depololarisation/repolarisation, enter comment
text
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
If other abnormalities, enter comment
Item
If other abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Repeat Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item Group
Repeat Visual Analogue Scale
C2959685 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0205341 (UMLS CUI-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])
Nose not runny/Nose extremely runny
Item
Nose not runny/Nose extremely runny
integer
C1260880 (UMLS CUI [1])
Nose clear/Nose completely blocked
Item
Nose clear/Nose completely blocked
integer
C0027424 (UMLS CUI [1])
Nose not itchy/Nose extremely itchy
Item
Nose not itchy/Nose extremely itchy
integer
C0850060 (UMLS CUI [1])
Nose not sore/Nose as sore as it has ever been
Item
Nose not sore/Nose as sore as it has ever been
integer
C0857495 (UMLS CUI [1])
Nose not dry/Nose as dry as it has ever been
Item
Nose not dry/Nose as dry as it has ever been
integer
C0231919 (UMLS CUI [1])
Throat not sore/Throat as sore as it has ever been
Item
Throat not sore/Throat as sore as it has ever been
integer
C0242429 (UMLS CUI [1])
Sense of taste normal/ Sense of taste completely abnormal
Item
Sense of taste normal/ Sense of taste completely abnormal
integer
C0039336 (UMLS CUI [1])
Taste nothing/Taste something very strongly
Item
Taste nothing/Taste something very strongly
integer
C1301555 (UMLS CUI [1])
Sense of smell normal/ Sense of smell completely abnormal
Item
Sense of smell normal/ Sense of smell completely abnormal
integer
C0037361 (UMLS CUI [1])
Smell nothing/Smell something very strongly
Item
Smell nothing/Smell something very strongly
integer
C2712084 (UMLS CUI [1])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
integer
C0231918 (UMLS CUI [1])
Item Group
Repeat Visual Nasal Endoscopy
C0189024 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0205341 (UMLS CUI-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
Abnormal, red (R)
CL Item
Abnormal, blue (B)
CL Item
Abnormal, 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
Abnormal, red (R)
CL Item
Abnormal, blue (B)
CL Item
Abnormal, 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])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
Code List
Left nostril concha media turbinate swelling
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)
CL Item
Normal (N)
CL Item
Right deviation (RD)
CL Item
Left deviation (LD)
CL Item
Not Done (ND)
Item
Severity of right deviation
text
C0232296 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Severity of left deviation
text
C0232297 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Left nostril secretions
text
C1720438 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
CL Item
Normal (N)
CL Item
Abnormal (A)
CL Item
Abnormal, Clear (CL)
CL Item
Abnormal, Opaque (OP)
CL Item
Abnormal, Purulent (PR)
Item
Right nostril secretions
text
C1720679 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
CL Item
Normal (N)
CL Item
Abnormal (A)
CL Item
Abnormal, Clear (CL)
CL Item
Abnormal, Opaque (OP)
CL Item
Abnormal, Purulent (PR)
CL Item
No infection (N)
CL Item
Viral infection (V)
CL Item
Bacterial infection (B)
CL Item
Absent (A)
CL Item
Present (P)
CL Item
Present, Clear (CL)
CL Item
Present, Opaque (OP)
CL Item
Present, Purulent (PR)
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
CL Item
No (N)
CL Item
Yes, specify location (Y)
If signs of bleeding, specify location
Item
If signs of bleeding, specify location
text
C0019080 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Not Done (ND)
CL Item
Absent (A)
CL Item
Yes, specify location (P)
If presece of nasal polyps, specify location
Item
If presece of nasal polyps, specify location
text
C0027430 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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