ID

16518

Description

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Screening Visit: Primary Diagnosis Physical Examination Vital Signs Height and Weight ECG: 12 Lead ECG

Lien

http://clinicaltrials.gov/show/NCT01416116

Mots-clés

Versions (3)
  1. 21/07/2016 21/07/2016 -
  2. 23/07/2016 23/07/2016 -
  3. 17/09/2021 17/09/2021 -
Téléchargé le

21 juillet 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Screening Visit 2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

Anglais

Screening Visit 2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 Formulaires  
Primary Diagnosis: Old diagnosis fields
Description

Primary Diagnosis: Old diagnosis fields

Diagnosis
Description

Diagnosis

Type de données

integer

Alias
UMLS CUI [1]
C0011900
Category
Description

Diagnosis Category

Type de données

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0683312
Primary Diagnosis: New diagnosis fields
Description

Primary Diagnosis: New diagnosis fields

Diagnosis
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1]
C0011900
Diagnosis Date
Description

Diagnosis Date

Type de données

date

Alias
UMLS CUI [1]
C2316983
Category
Description

Category

Type de données

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0683312
If 'Other', specify
Description

Other

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205394
Physical Examination
Description

Physical Examination

Was the Physical Examination performed?
Description

If the Physical Examination was performed, please provide the Assessment Date below.

Type de données

text

Alias
UMLS CUI [1]
C0031809
Assessment Date
Description

Record any clinically significant abnormal findings/conditions identified during the exam on the Medical and Surgical History and/or Adverse Events form.

Type de données

date

Alias
UMLS CUI [1]
C2826643
Vital Signs
Description

Vital Signs

Assessment Date
Description

vital signs date

Type de données

date

Alias
UMLS CUI [1]
C2826644
Position
Description

Position

Type de données

integer

Systolic Blood Pressure
Description

Systolic Blood Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Height and Weight
Description

Height and Weight

Assessment Date
Description

Height and Weight Date

Type de données

date

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0005910
UMLS CUI [1,3]
C0011008
Height
Description

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECG: 12 Lead ECG
Description

ECG: 12 Lead ECG

Date ECG Performed
Description

Date ECG Performed

Type de données

date

Alias
UMLS CUI [1]
C2826846
ECG Interpretation
Description

ECG Interpretation

Type de données

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0459471
Abnormality Code
Description

ECG Abnormality

Type de données

integer

Alias
UMLS CUI [1]
C1832603
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Similar models

Screening Visit 2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Primary Diagnosis: Old diagnosis fields
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Postherpetic Neuralgia (1 )
CL Item
Post Traumatic Peripheral Neuropathic Pain Syndrome (2 )
Item
Category
integer
C0011900 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Diagnosis Category
Code List
Category
CL Item
Post-surgical (1 )
CL Item
Peripheral Nerve Injury (2 )
CL Item
Other (99 )
Item Group
Primary Diagnosis: New diagnosis fields
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Diagnosis Date
Item
Diagnosis Date
date
C2316983 (UMLS CUI [1])
Item
Category
integer
C0011900 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Category
Code List
Category
CL Item
Post-traumatic (1 )
CL Item
Post-surgical (2 )
CL Item
Other (99)
Other
Item
If 'Other', specify
text
C0011900 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Physical Examination
Item
Was the Physical Examination performed?
text
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Was the Physical Examination performed?
CL Item
No (0 )
CL Item
Yes (1 )
Physical Examination Date
Item
Assessment Date
date
C2826643 (UMLS CUI [1])
Item Group
Vital Signs
vital signs date
Item
Assessment Date
date
C2826644 (UMLS CUI [1])
Item
Position
integer
Position
Code List
Position
CL Item
Supine (1 )
CL Item
Sitting (2 )
CL Item
Standing (3 )
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
Item Group
Height and Weight
Height and Weight Date
Item
Assessment Date
date
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
ECG: 12 Lead ECG
Date ECG Performed
Item
Date ECG Performed
date
C2826846 (UMLS CUI [1])
Item
ECG Interpretation
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
ECG Interpretation
Code List
ECG Interpretation
CL Item
Normal (0 )
CL Item
Abnormal - not clinically significant (1 )
CL Item
Abnormal - clinically significant (2 )
Item
Abnormality Code
integer
C1832603 (UMLS CUI [1])
ECG Abnormality
Code List
Abnormality Code
CL Item
Sinus Tachycardia (101 )
CL Item
Sinus Bradycardia (102 )
CL Item
Atrial tachycardia - Without Block (103 )
CL Item
Atrial Tachycardia - With Block (104 )
CL Item
Atrial Flutter (105 )
CL Item
Atrial Fibrillation (106 )
CL Item
PSVT(Paroxy smal Supraventricul ar Tachycardia) (107 )
CL Item
Variable Atrial Pacemaker (108 )
CL Item
Junctional Rhythm Without Aberrancy (109 )
CL Item
Junctional Rhythm With Aberrancy (110 )
CL Item
Ventricular Rhythm (111 )
CL Item
Ventricular Tachycardia (112 )
CL Item
Accelerated AV Conduction Pattern (113 )
CL Item
Wolff - Parkinson - White Pattern (114 )
CL Item
Supraventricular Ectopic Beats (115 )
CL Item
Ventricular Ectopic Beats – Unifocal (116 )
CL Item
Ventricular Ectopic Beats - Multifocal (117 )
CL Item
Pacemaker Rhythm (118 )
CL Item
Ventricular Fibrillation (119 )
CL Item
Sinus Arrest (120 )
CL Item
SinusArrhythmia (121 )
CL Item
Nodal Tachycardia (122 )
CL Item
LGL Syndrome (123 )
CL Item
Junctional escape complexes (124 )
CL Item
Sino - Atrial Block (125 )
CL Item
First Degree AV Block (301 )
CL Item
Second Degree AV Block - Mobitz I (302 )
CL Item
Second Degree AV Block - Mobitz II (303 )
CL Item
Complete AV Block (304 )
CL Item
Prolonged QT Interval (401 )
CL Item
Prolonged QTc interval (402 )
CL Item
Right Atrial Enlargement (601 )
CL Item
Left Atrial Enlargement (602 )
CL Item
P-Wave Abnormality (603 )
CL Item
AV Dissociation (701 )
CL Item
Left Anterior Hemiblock (702 )
CL Item
Left Posterior Hemiblock (703 )
CL Item
Right Bundle Branch Block (704 )
CL Item
Incomplete Right Bundle Branch Block (705 )
CL Item
Left Bundle Branch Block (706 )
CL Item
Incomplete Left Bundle Branch Block (707 )
CL Item
Nonspecific Intraventricula r Conduction Delay (708 )
CL Item
Bifascicular Block (709 )
CL Item
Left Axis Deviation (710 )
CL Item
Right Axis Deviation (711 )
CL Item
Abnormal QRS Axis (712 )
CL Item
Left Ventricular Hypertrophia (713 )
CL Item
Left Ventricular Hypertrophia By Voltage Only (714 )
CL Item
Right Ventricular Hypertrophia (715 )
CL Item
Old Myocardial Infarction: Antero septal (716 )
CL Item
Old Myocardial Infarction: Antero lateral (717 )
CL Item
Old Myocardial Infarction: Infero lateral (718 )
CL Item
Old Myocardial Infarction: Infero posterior (719 )
CL Item
Old Myocardial Infarction: Postero lateral (720 )
CL Item
Old Myocardial Infarction: Lateral (721 )
CL Item
Low Voltage QRS Complex (722 )
CL Item
Poor R-Wave Progression (723 )
CL Item
Late R-Wave Transition (724 )
CL Item
Early Repolarization – Normal Variant (725 )
CL Item
Early R-Wave Transition (726 )
CL Item
New Myocardial Infarction: Antero septal (801 )
CL Item
New Myocardial Infarction: Antero lateral (802 )
CL Item
New Myocardial Infarction: Infero lateral (803 )
CL Item
New Myocardial Infarction: Infero posterior (804 )
CL Item
New Myocardial Infarction: Postero lateral (805 )
CL Item
New Myocardial Infarction: Lateral (806 )
CL Item
Myocardial Infarction – Nontransmural -Acute or Evolving (807 )
CL Item
ST Elevation Consistent with Ischaemia: Anterior  (808 )
CL Item
ST Elevation Consistent with Ischaemia: Septal  (809 )
CL Item
ST Elevation Consistent with Ischaemia: Lateral (810 )
CL Item
ST Elevation Consistent with Ischaemia: Inferior (811 )
CL Item
ST Elevation Consistent with Ischaemia: Posterior (812 )
CL Item
ST Elevation Consistent with Ischaemia:High Lateral (813 )
CL Item
ST Elevation Consistent With Pericarditis (814 )
CL Item
Non-Specific ST-T Change (815 )
CL Item
ST-T changes - Consistent With Drug Effects (816 )
CL Item
ST Depression: Anterior (817 )
CL Item
ST Depression: Septal (818 )
CL Item
ST Depression: Lateral (819 )
CL Item
ST Depression: Inferior (820 )
CL Item
ST Depression: Posterior (821 )
CL Item
ST Depression: High Lateral (822 )
CL Item
ST Depression - Non-Specific (823 )
CL Item
T-Wave Inversion Suggestive of Non-Q-Wave MI (901 )
CL Item
T-Wave Flattening or Inversion in Two or More Leads (902 )
CL Item
Non-Specific T-Wave changes (903 )
CL Item
T-Wave Inversion Suggestive of Ischaemia (904 )
CL Item
T-Wave Peaking 998 = U-Wave Abnormality (905 )
CL Item
Other (999 )
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