A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients - Tabular View

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A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

This study is currently recruiting participants.
Information provided by Merrion Pharmaceuticals, LLC

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Descriptive Information Fields
Brief Title ^†	A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Official Title ^†	A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
Brief Summary	The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	Effects on 4 markers of bone metabolism [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	Brief Pain Inventory [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Condition ^†	Hormone-Refractory Prostate Cancer
Intervention ^†	Drug: Zoledronic Acid 20mg Tablets Drug: Zoledronic Acid Drug: Zoledronic Acid 20mg Tablets
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†	30
Start Date ^†	February 2008
Completion Date	November 2008
Eligibility Criteria ^†	Inclusion Criteria: Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray. Exclusion Criteria: Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00636740
Organization ID	MER-101-03
Secondary IDs ^††
Study Sponsor ^†	Merrion Pharmaceuticals, LLC
Collaborators ^††
Investigators ^†
Information Provided By	Merrion Pharmaceuticals, LLC
Verification Date	March 2008
First Received Date ^†	March 7, 2008
Last Updated Date	March 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.