NCT00636740已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Effects on 4 markers of bone metabolism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
排除标准
- •Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
研究组 & 干预措施
B
Experimental
MER-101 20mg Tablets Regimen 1
干预措施: Zoledronic Acid 20mg Tablets (Drug)
C
Experimental
MER-101 20mg Tablets Regimen 2
干预措施: Zoledronic Acid 20mg Tablets (Drug)
A
Active Comparator
Zometa Injection
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Effects on 4 markers of bone metabolism
时间窗: Weekly
次要结局
- Brief Pain Inventory(Monthly)
研究者
研究点 (13)
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A multi-center Phase II study to compare MER-101 20mg tablets to intravenous Zometa® 4mg in male bisphosphonate-naïve, hormone-refractory prostate cancer patientsEUCTR2008-001395-74-LVMerrion Pharmaceuticals plc30
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