ID

16863

Beschrijving

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: NPRS 'pain now' score: 75 mins prior to patch NPRS 'pain now' score: 40, 15 mins prior to patch NPRS 'pain now' score: Post patch application and post patch removal Tolerability score: Post patch removal NPRS 'average pain' score: Day 1-3 NPRS 'pain now' score: Day 1-3

Link

http://clinicaltrials.gov/show/NCT01416116

Trefwoorden

  1. 11-08-16 11-08-16 -
Geüploaded op

11 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Treatment Visit Form 5/5 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

    Treatment Visit Form 5/5 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

    NPRS 'pain now' score: 75 mins prior to patch
    Beschrijving

    NPRS 'pain now' score: 75 mins prior to patch

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    75 mins prior to patch application

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    NPRS 'pain now' score
    Beschrijving

    NPRS 'pain now' score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0582148 (Pain score)
    SNOMED
    225908003
    LOINC
    LP156436-0
    NPRS 'pain now' score: 40, 15 mins prior to patch
    Beschrijving

    NPRS 'pain now' score: 40, 15 mins prior to patch

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    Scheduled Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    NPRS 'pain now' score
    Beschrijving

    NPRS 'pain now' score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0582148 (Pain score)
    SNOMED
    225908003
    LOINC
    LP156436-0
    NPRS 'pain now' score: Post patch application and post patch removal
    Beschrijving

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

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    75 mins prior to patch application

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    NPRS 'pain now' score
    Beschrijving

    NPRS 'pain now' score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0582148 (Pain score)
    SNOMED
    225908003
    LOINC
    LP156436-0
    Tolerability score: Post patch removal
    Beschrijving

    Tolerability score: Post patch removal

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    75 mins prior to patch application

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    Tolerability score
    Beschrijving

    120 mins post patch removal

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3274448 (Tolerability Study)
    NPRS 'average pain' score: Day 1-3
    Beschrijving

    NPRS 'average pain' score: Day 1-3

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    Scheduled Time

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    NPRS 'average pain' score
    Beschrijving

    NPRS 'average pain' score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0582148 (Pain score)
    SNOMED
    225908003
    LOINC
    LP156436-0
    Form: NPRS 'pain now' score: Day 1-3
    Beschrijving

    Form: NPRS 'pain now' score: Day 1-3

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Scheduled Time
    Beschrijving

    75 mins prior to patch application

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Assessment Time
    Beschrijving

    Assessment Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1516048 (Assessed)
    NPRS 'pain now' score
    Beschrijving

    NPRS 'pain now' score

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0582148 (Pain score)
    SNOMED
    225908003
    LOINC
    LP156436-0

    Similar models

    Treatment Visit Form 5/5 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

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    NPRS 'pain now' score: 75 mins prior to patch
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    NPRS 'pain now' score
    integer
    C0582148 (UMLS CUI [1])
    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
    NPRS 'pain now' score: 40, 15 mins prior to patch
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    NPRS 'pain now' score
    integer
    C0582148 (UMLS CUI [1])
    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
    NPRS 'pain now' score: Post patch application and post patch removal
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    NPRS 'pain now' score
    integer
    C0582148 (UMLS CUI [1])
    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])
    Scheduled Time
    Item
    Scheduled Time
    time
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    Tolerability score
    integer
    C3274448 (UMLS CUI [1])
    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
    NPRS 'average pain' score: Day 1-3
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Scheduled Time
    integer
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Code List
    Scheduled Time
    CL Item
    Day 1 (Day of Patch Application) (1)
    CL Item
    Day 2 (2)
    CL Item
    Day 3 (3)
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    NPRS 'average pain' score
    integer
    C0582148 (UMLS CUI [1])
    Code List
    NPRS 'average pain' 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
    Form: NPRS 'pain now' score: Day 1-3
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Scheduled Time
    integer
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Code List
    Scheduled Time
    CL Item
    1: Day 1 (Day of Patch Application) (1)
    CL Item
    2: Day 2 (2)
    CL Item
    3: Day 3 (3)
    Assessment Time
    Item
    Assessment Time
    time
    C0040223 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item
    NPRS 'pain now' score
    integer
    C0582148 (UMLS CUI [1])
    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)

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