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

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

February 19, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects on 4 markers of bone metabolism [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00636740 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Brief Pain Inventory [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hormone-Refractory Prostate Cancer

Intervention ^ICMJE

Drug: Zoledronic Acid 20mg Tablets
Drug: Zoledronic Acid
Drug: Zoledronic Acid 20mg Tablets

Study Arms / Comparison Groups

Experimental: MER-101 20mg Tablets Regimen 1
Experimental: MER-101 20mg Tablets Regimen 2
Active Comparator: Zometa Injection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Estonia, Latvia

Administrative Information

NCT ID ^ICMJE

NCT00636740

Responsible Party

Thomas W. Leonard, PhD, Merrion Pharmaceuticals, LLC

Study ID Numbers ^ICMJE

MER-101-03

Study Sponsor ^ICMJE

Merrion Pharmaceuticals, LLC

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Thomas W Leonard, PhD

Merrion Pharmaceuticals, LLC

Information Provided By

Merrion Pharmaceuticals, LLC

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP