0 Evaluaciones
ID

16518

Descripción

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

Palabras clave

Versiones (3)
  1. 21/7/16 21/7/16 -
  2. 23/7/16 23/7/16 -
  3. 17/9/21 17/9/21 -
Subido en

21 de julio de 2016

DOI

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Licencia

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

    Inglés

    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 formularios  
    Primary Diagnosis: Old diagnosis fields
    Descripción

    Primary Diagnosis: Old diagnosis fields

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0011900
    Category
    Descripción

    Diagnosis Category

    Tipo de datos

    integer

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

    Primary Diagnosis: New diagnosis fields

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0011900
    Diagnosis Date
    Descripción

    Diagnosis Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2316983
    Category
    Descripción

    Category

    Tipo de datos

    integer

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

    Other

    Tipo de datos

    text

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

    Physical Examination

    Was the Physical Examination performed?
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0031809
    Assessment Date
    Descripción

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

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826643
    Vital Signs
    Descripción

    Vital Signs

    Assessment Date
    Descripción

    vital signs date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826644
    Position
    Descripción

    Position

    Tipo de datos

    integer

    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse Rate
    Descripción

    Pulse Rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Height and Weight
    Descripción

    Height and Weight

    Assessment Date
    Descripción

    Height and Weight Date

    Tipo de datos

    date

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

    Height

    Tipo de datos

    integer

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    ECG: 12 Lead ECG
    Descripción

    ECG: 12 Lead ECG

    Date ECG Performed
    Descripción

    Date ECG Performed

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826846
    ECG Interpretation
    Descripción

    ECG Interpretation

    Tipo de datos

    integer

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

    ECG Abnormality

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1832603
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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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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