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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 has been completed.
Sponsor:
Information provided by:
Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00636740
First received: March 7, 2008
Last updated: February 19, 2009
Last verified: February 2009

March 7, 2008
February 19, 2009
February 2008
February 2009   (final data collection date for primary outcome measure)
Effects on 4 markers of bone metabolism [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00636740 on ClinicalTrials.gov Archive Site
Brief Pain Inventory [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone-Refractory Prostate Cancer
  • Drug: Zoledronic Acid 20mg Tablets
    Oral enteric coated tablets, 20mg, weekly, 8 weeks
    Other Name: MER-101
  • Drug: Zoledronic Acid
    Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
    Other Name: Zometa
  • Drug: 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 Name: MER-101
  • Experimental: B
    MER-101 20mg Tablets Regimen 1
    Intervention: Drug: Zoledronic Acid 20mg Tablets
  • Experimental: C
    MER-101 20mg Tablets Regimen 2
    Intervention: Drug: Zoledronic Acid 20mg Tablets
  • Active Comparator: A
    Zometa Injection
    Intervention: Drug: Zoledronic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2009
February 2009   (final data collection date for primary outcome measure)

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)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Estonia,   Latvia
 
NCT00636740
MER-101-03
No
Thomas W. Leonard, PhD, Merrion Pharmaceuticals, LLC
Merrion Pharmaceuticals, LLC
Not Provided
Study Director: Thomas W Leonard, PhD Merrion Pharmaceuticals, LLC
Merrion Pharmaceuticals, LLC
February 2009

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