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ID

17013

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 End of Study End of Study

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (1)
  1. 8/21/16 8/21/16 -
Uploaded on

August 21, 2016

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License

Creative Commons BY 4.0
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    End of Study Form 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

    English

    End of Study Form 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 forms  
    End of Study
    Description

    End of Study

    Did subject complete the study?
    Description

    If 'NO', please provide details below.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348577 (Subject Completed Participation in Study)
    Withdrawal Date
    Description

    Withdrawal Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Primary Reason for Withdrawal
    Description

    If 'Primary Reason for Withdrawal' is 'Adverse Event', please provide details on 'Adverse Event' form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    undefined item
    Description

    undefined item

    Data type

    integer

    If 'Protocol Violation', specify
    Description

    Protocol Violation

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709750 (Protocol Violation)
    If 'Other', specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
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    Similar models

    End of Study Form 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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    End of Study
    Item
    Did subject complete the study?
    integer
    C2348577 (UMLS CUI [1])
    study complete
    Code List
    Did subject complete the study?
    CL Item
    no (0)
    CL Item
    yes (1)
    Withdrawal Date
    Item
    Withdrawal Date
    date
    C2349954 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Reason for Withdrawal
    Item
    Primary Reason for Withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item
    integer
    undefined item
    Code List
    undefined item
    CL Item
    Adverse event (1 )
    CL Item
    Withdrawal of consent (2 )
    CL Item
    Subject lost to follow up (3 )
    CL Item
    Protocol violation (4 )
    CL Item
    Pregnancy (5 )
    CL Item
    Other (6 )
    Protocol Violation
    Item
    If 'Protocol Violation', specify
    text
    C1709750 (UMLS CUI [1])
    Other
    Item
    If 'Other', specify
    text
    C0205394 (UMLS CUI [1])
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