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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

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (3)
  1. 7/21/16 7/21/16 -
  2. 7/23/16 7/23/16 -
  3. 9/17/21 9/17/21 -
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July 21, 2016

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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

    English

    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 forms  
    Primary Diagnosis: Old diagnosis fields
    Description

    Primary Diagnosis: Old diagnosis fields

    Diagnosis
    Description

    Diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Category
    Description

    Diagnosis Category

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0683312 (Categories)
    LOINC
    MTHU018876
    Primary Diagnosis: New diagnosis fields
    Description

    Primary Diagnosis: New diagnosis fields

    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Diagnosis Date
    Description

    Diagnosis Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2316983 (Date of diagnosis)
    SNOMED
    432213005
    LOINC
    LP114957-6
    Category
    Description

    Category

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0683312 (Categories)
    LOINC
    MTHU018876
    If 'Other', specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Physical Examination
    Description

    Physical Examination

    Was the Physical Examination performed?
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    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.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    Vital Signs
    Description

    Vital Signs

    Assessment Date
    Description

    vital signs date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644 (Vital Signs Date)
    Position
    Description

    Position

    Data type

    integer

    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Pulse Rate
    Description

    Pulse Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    bpm
    Height and Weight
    Description

    Height and Weight

    Assessment Date
    Description

    Height and Weight Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005890 (Body Height)
    SNOMED
    50373000
    UMLS CUI [1,2]
    C0005910 (Body Weight)
    SNOMED
    27113001
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    ECG: 12 Lead ECG
    Description

    ECG: 12 Lead ECG

    Date ECG Performed
    Description

    Date ECG Performed

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826846 (Electrocardiogram Collection Date Time)
    ECG Interpretation
    Description

    ECG Interpretation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    UMLS CUI [1,2]
    C0459471 (Interpretation Process)
    SNOMED
    280452008
    LOINC
    LP21032-5
    Abnormality Code
    Description

    ECG Abnormality

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1832603 (undefined)
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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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 )
    Back to the top of the page 

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