Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009648

Trial Description

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Title

YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine if patients who take YM598 in addition to
mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated
with prostate cancer metastases in the bone.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00009648
  •   2015/11/11
  •   2002/11/04
  •   no
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Secondary IDs

  •   NCT00048659  (ClinicalTrials.gov)
  •   598-CL-008  (Astellas Pharma Inc)
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Health Condition or Problem studied

  •   Hormone-Refractory Prostate Cancer
  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: YM598
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   Australia
  •   Belgium
  •   France
  •   Germany
  •   Ireland
  •   Netherlands
  •   Poland
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

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  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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Exclusion Criteria

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Addresses

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    • Astellas Pharma Inc
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    • Astellas Pharma US, Inc.
    end of 1:1-Block address other
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2004/06/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/11/10


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