Trial document




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  DRKS00005189

Trial Description

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Title

Qutenza TM in notalgia paresthtetica: pharmacoeconomic evaluation and patient acceptance with focus on intraepidermal C-fiber eradication

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to evaluate pharmacoeconomics and acceptance of Qutenza patch for patients suffering from notalgia paraesthetica or brachioradial pruritus. It should be evaluated if application decreases follow up costs of treatments and correlates with intraepidermal nerve fiber density.

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Brief Summary in Scientific Language

The aim of the study is to document therapy with neuropathic pain syndromes such as Qutenza in a series of patients suffering from notalgia paraesthetica or brachioradial pruritus with special focus on
1. the economic evaluation of therapies incl. treatment regimens under consideration of symptom changes and
2. the patient acceptance of Qutenza with regard to clinical symptoms (Pruritus, Burning, Pain e.g.), quality of life, fear and depression.
As objectiv marker of treatment effectiveness intraepidermal nerv growth is used.
Data will be collected 6 and 3 months retrospectively and prospectivels. Nerve growth will be analyzed at time of application as well as 3, 12, and 24 weeks after.


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Organizational Data

  •   DRKS00005189
  •   2013/09/10
  •   [---]*
  •   no
  •   Approved
  •   2011-462-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   M79.29 -  [generalization M79.2: Neuralgia and neuritis, unspecified]
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Interventions/Observational Groups

  •   Patients with Notalgia paraesthetica or brachioradial pruritus fill out several questionaires concerning clinical symptoms, quality of life and medical treatment regimens/costs and are treated with Qutenza if indicated. Within routine a skin biospy is taken.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health economics
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Pharmacoeconomic and clinical evaluation of prescription patterns, symptoms, quality of life and nerve growth 3/6 months retrospectively and 3/6 months prospectively.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/05/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Diagnosis of notalgia paraesthetica or brachioradial pruritus with actual therapy need

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Exclusion Criteria

Exclusion.
1. current and past (last 2 weeks) use of topical or systemic pain modulators (e.g., local anaesthetics in NP area, gabapentin, pregabalin), antidepressants (e.g., paroxetine, fluvoxamine, amitriptyline), antihistamines, topical or systemic steroids
2. diabetes, uncontrolled hypertension
3. history of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients, allergy to capsaicin
4. pregnancy, breast feeding
5. active psychosomatic and psychiatric diseases necessitating drug treatment
6. participation in any other research study during the previous 4 weeks.
7. previous participation in this study

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Addresses

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    • Astellas Pharma
    • 80992  München
    • Germany
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    • Hautklinik UKM
    • Univ.-Prof. Dr. med.  Sonja  Ständer 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
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    • Hautklinik UKM
    • Sabine  Stoll 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Astellas Pharma
    • 80992  München
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.