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16867

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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 Treatment Visit Form 2/5: Randomization Vital Signs: 75 mins prior to patch application Vital Signs: 15 mins prior to patch application Post patch application and post patch removal

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http://clinicaltrials.gov/show/NCT01416116

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Versions (2)
  1. 24/07/2016 24/07/2016 -
  2. 11/08/2016 11/08/2016 -
Téléchargé le

11 août 2016

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Creative Commons BY 4.0
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    Treatment Visit Form 2/5 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

    Treatment Visit Form 2/5 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  
    Randomization
    Description

    Randomization

    Date of Randomization
    Description

    Date of Randomization

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Randomization Number
    Description

    Randomization Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C0034656
    Dose/Group
    Description

    Dose/Group

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C0441833
    Vital Signs: 75 mins prior to patch application
    Description

    Vital Signs: 75 mins prior to patch application

    Assessment Date
    Description

    Assessment Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720
    Scheduled Time
    Description

    Scheduled Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0086960
    Assessment Time
    Description

    Assessment Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Position
    Description

    Position

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0733755
    Systolic Blood Pressure
    Description

    For any AE, please provide details on the 'Adverse Event' form.

    Type de données

    text

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

    Diastolic Blood Pressure

    Type de données

    text

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

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

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0232117
    Vital Signs: 15 mins prior to patch application
    Description

    Vital Signs: 15 mins prior to patch application

    Assessment Date
    Description

    Assessment Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720
    Scheduled Time
    Description

    Scheduled Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0086960
    Assessment Time
    Description

    Assessment Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Position
    Description

    Position

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0733755
    Systolic Blood Pressure
    Description

    For any AE, please provide details on the 'Adverse Event' form.

    Type de données

    text

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

    Diastolic Blood Pressure

    Type de données

    text

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

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

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0232117
    Vital Signs: Post patch application and post patch rGeemnoevraatl
    Description

    Vital Signs: Post patch application and post patch rGeemnoevraatl

    Assessment Date
    Description

    Assessment Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720
    Scheduled Time
    Description

    Scheduled Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0086960
    Assessment Time
    Description

    Assessment Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Position
    Description

    Position

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0733755
    Systolic Blood Pressure
    Description

    For any AE, please provide details on the 'Adverse Event' form.

    Type de données

    text

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

    Diastolic Blood Pressure

    Type de données

    text

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

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

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0232117
    Retour au début de la page

    Similar models

    Treatment Visit Form 2/5 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
    Randomization
    Date of Randomization
    Item
    Date of Randomization
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Randomization Number
    Item
    Randomization Number
    integer
    C0030705 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C0034656 (UMLS CUI [1,3])
    Item
    Dose/Group
    integer
    C3174092 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C0441833 (UMLS CUI [1,3])
    Dose/Group
    Code List
    Dose/Group
    CL Item
    Arm 1: Lidocaine 4% (1)
    CL Item
    Arm 2: Tramadol (2)
    Item Group
    Vital Signs: 75 mins prior to patch application
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0086960 (UMLS CUI [1])
    Assessment Time
    Item
    Assessment Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Position
    integer
    C0733755 (UMLS CUI [1])
    Position
    Code List
    Position
    CL Item
    Supine (1 )
    CL Item
    Sitting (2 )
    CL Item
    Standing (3 )
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    text
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    text
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse Rate
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Vital Signs: 15 mins prior to patch application
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0086960 (UMLS CUI [1])
    Assessment Time
    Item
    Assessment Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Position
    integer
    C0733755 (UMLS CUI [1])
    Position
    Code List
    Position
    CL Item
    Supine (1 )
    CL Item
    Sitting (2 )
    CL Item
    Standing (3 )
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    text
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    text
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse Rate
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Vital Signs: Post patch application and post patch rGeemnoevraatl
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0086960 (UMLS CUI [1])
    Assessment Time
    Item
    Assessment Time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Position
    integer
    C0733755 (UMLS CUI [1])
    Position
    Code List
    Position
    CL Item
    Supine (1 )
    CL Item
    Sitting (2 )
    CL Item
    Standing (3 )
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    text
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    text
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse Rate
    integer
    C0232117 (UMLS CUI [1])
    Retour au début de la page 

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