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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 4, 2002 |
| Last Updated Date | March 31, 2006 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00048659 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy |
| Official Title ICMJE | |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: YM598 |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | |
| Gender | Male |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Australia, Belgium, France, Germany, Ireland, Netherlands, Poland, Spain, United Kingdom |
| Administrative Information | |
| NCT ID ICMJE | NCT00048659 |
| Responsible Party | |
| Study ID Numbers ICMJE | 598-CL-008 |
| Study Sponsor ICMJE | Astellas Pharma Inc |
| Collaborators ICMJE | Astellas Pharma US, Inc. |
| Investigators ICMJE | |
| Information Provided By | Astellas Pharma Inc |
| Verification Date | March 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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