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ID

16871

Beskrivning

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 End of Study Form 1/: Vital Signs Identification of Painful Area: Change NPRS 'average pain' score NPRS 'pain now' score Adverse Event 1 Concomitant Medication 1 Any Non-medication Therapy

Länk

http://clinicaltrials.gov/show/NCT01416116

Nyckelord

Versioner (1)
  1. 2016-08-11 2016-08-11 -
Uppladdad den

11 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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    End of Study Form 1/ 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

    Engelsk

    End of Study Form 1/ 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 Formulär  
    Vital Signs: 75 mins prior to patch application
    Beskrivning

    Vital Signs: 75 mins prior to patch application

    Date of Visit
    Beskrivning

    Date of Visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Assessment Date
    Beskrivning

    Assessment Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Position
    Beskrivning

    Position

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0733755
    Systolic Blood Pressure
    Beskrivning

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

    Datatyp

    text

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Beskrivning

    Diastolic Blood Pressure

    Datatyp

    text

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse Rate
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0232117
    Identification of Painful Area: Change
    Beskrivning

    Identification of Painful Area: Change

    Is there any change in most painful area?
    Beskrivning

    If ‘Yes’, please provide details on 'Identification of Painful Area'

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0392747
    NPRS 'average pain' score
    Beskrivning

    NPRS 'average pain' score

    Date of Assessment
    Beskrivning

    Date of Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    NPRS 'average' pain score
    Beskrivning

    NPRS 'average' pain score

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0582148
    NPRS 'pain now' score: Post patch application and post patch removal
    Beskrivning

    NPRS 'pain now' score: Post patch application and post patch removal

    Date of Assessment
    Beskrivning

    Date of Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    NPRS 'pain now' score
    Beskrivning

    NPRS 'pain now' score

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0582148
    Tolerability score: Post patch removal
    Beskrivning

    Tolerability score: Post patch removal

    Date of Assessment
    Beskrivning

    Date of Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Tolerability score
    Beskrivning

    120 mins post patch removal

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3274448
    Additional Information
    Beskrivning

    Additional Information

    Was any adverse event reported or observed?
    Beskrivning

    If 'Yes', please provide details on 'Adverse Event' form.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Is there any previous medication and /or concomitant medication to record?
    Beskrivning

    Concomitant medication

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2347852
    Is there any non-medication therapy and/or changes in non-medication therapy to record?
    Beskrivning

    If 'Yes', please provide details on 'Non-medication Therapy' form.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C1518422
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    Similar models

    End of Study Form 1/ 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 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Vital Signs: 75 mins prior to patch application
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    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
    Identification of Painful Area: Change
    Item
    Is there any change in most painful area?
    integer
    C0030193 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    Pain Change
    Code List
    Is there any change in most painful area?
    CL Item
    no (0)
    CL Item
    yes (1)
    Item Group
    NPRS 'average pain' score
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    NPRS 'average' pain score
    integer
    C0582148 (UMLS CUI [1])
    NPRS 'average' pain score
    Code List
    NPRS 'average' pain score
    CL Item
    0 (0 )
    CL Item
    1 (1 )
    CL Item
    2 (2 )
    CL Item
    3 (3 )
    CL Item
    4 (4 )
    CL Item
    5 (5 )
    CL Item
    6 (6 )
    CL Item
    7 (7 )
    CL Item
    8 (8 )
    CL Item
    9 (9 )
    CL Item
    10 (10 )
    Item Group
    NPRS 'pain now' score: Post patch application and post patch removal
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    NPRS 'pain now' score
    integer
    C0582148 (UMLS CUI [1])
    NPRS 'pain now' score
    Code List
    NPRS 'pain now' score
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item Group
    Tolerability score: Post patch removal
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Tolerability score
    integer
    C3274448 (UMLS CUI [1])
    NPRS 'pain now' score
    Code List
    Tolerability score
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item Group
    Additional Information
    Item
    Was any adverse event reported or observed?
    integer
    C0877248 (UMLS CUI [1])
    adverse event
    Code List
    Was any adverse event reported or observed?
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Is there any previous medication and /or concomitant medication to record?
    integer
    C2347852 (UMLS CUI [1])
    Concomitant medication
    Code List
    Is there any previous medication and /or concomitant medication to record?
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Is there any non-medication therapy and/or changes in non-medication therapy to record?
    integer
    C0087111 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    non-medication therapy
    Code List
    Is there any non-medication therapy and/or changes in non-medication therapy to record?
    CL Item
    no (0)
    CL Item
    yes (1)
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