Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
NCT ID: NCT00636740
Last Updated: 2009-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2008-02-29
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
MER-101 20mg Tablets Regimen 1
Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
C
MER-101 20mg Tablets Regimen 2
Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
A
Zometa Injection
Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Interventions
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Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Merrion Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Merrion Pharmaceuticals, LLC
Principal Investigators
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Thomas W Leonard, PhD
Role: STUDY_DIRECTOR
Merrion Pharmaceuticals, LLC
Locations
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Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, United States
Cancer Care of North Florida, P.A.
Lake City, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States
Green Clinic, LLC
Ruston, Louisiana, United States
New York Urological Associates, PC
New York, New York, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Cancer Outreach Associates, P.C.
Abingdon, Virginia, United States
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonian Regional Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
O. Hublarovs Private Practice
Daugavpils, , Latvia
P. Stradina Clinical University Hospital
Riga, , Latvia
Countries
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Other Identifiers
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MER-101-03
Identifier Type: -
Identifier Source: org_study_id
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