Trial document




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  DRKS00008185

Trial Description

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Title

Non-interventional study to evaluate neurotoxicity under therapy with Paclitaxel Omnicare for patients with various tumor entities

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Trial Acronym

NEPAL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study evaluates (by means of a patient questionnaire) neurological symptoms of patients with various cancer types who receive a therapy with Paclitaxel Omnicare®

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Brief Summary in Scientific Language

The study evaluates neurotoxicity under therapy with Paclitaxel Omnicare® for patients with various tumor entities

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Organizational Data

  •   DRKS00008185
  •   2015/04/28
  •   [---]*
  •   no
  •   Approved
  •   2015092, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
  •   C50 -  Malignant neoplasm of breast
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patients treated with Paclitaxel Omnicare are asked to complete a questionnaire every 3 months under therapy and every 6 months after end of treatment. The questionnaire contains questions regarding the effect of treatment on daily life activities and general health condition of the patients.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Evaluation of grade and duration of neurotoxicity for patients (every 3 months under therapy and every 6 months after end of treatment) under therapy with Paclitaxel Omnicare by means of a patient questionnaire (FACT-GOG-Ntx)

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Secondary Outcome

• Evaluation of neurotoxicity by the investigator by means of CTCAE criteria (version 4.0)
• Evaluation of adverse drug reactions of Paclitaxel Omnicare®

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/07/02
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Male and female patients ≥ 18 years
2. Diagnosis of tumor disease for which a chemotherapy with Paclitaxel Omnicare is indicated
3. Investigator's decision (independent of study participation) to treat the patient with Paclitaxel Omnicare®
4. Sufficient patient's compliance upon investigator's assessment
5. Written informed consent of the patient to retrospective and prospective pseudonomized documentation, to forwarding and analysis of the data and to access to the data within monitoring

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Exclusion Criteria

None

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Addresses

  • start of 1:1-Block address primary-sponsor
    • OMNICARE Pharma GmbH
    • Ms.  Dr.  Christine  Schneider 
    • Feringastr. 7
    • 85774  Unterföhring
    • Germany
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    • Praxis Drs. Losem/Plewe
    • Mr.  Dr. med.  Christoph  Losem 
    • Am Hasenberg 44
    • 41462  Neuss
    • Germany
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    •   02131 - 10 12 06
    •   02131 - 10 20 96
    •   losem at plelo.de
    •   [---]*
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    • Institut Dr. Schauerte
    • Mr.  Martin  Orlovius 
    • Finkenstr. 7
    • 80333  München
    • Germany
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Sources of Monetary or Material Support

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    • OMNICARE Pharma GmbH
    • Ms.  Dr.  Christine  Schneider 
    • Feringastr. 7
    • 85774  Unterföhring
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.