NCT01539265已完成2 期
A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi
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
- 300
- 试验地点
- 1
- 主要终点
- Spontaneous stone passage rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week
- •Patients who are able to visit the site continually as out-patient during the study
排除标准
- •Patients who have multiple urethral stones.
- •Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
- •Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
- •Patients who have a clinically significant hepatic or renal disorder.
- •Patients with postural hypotension or with a history of postural hypotension.
- •Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
- •Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
silodosin, arm 1
Experimental
干预措施: silodosin (Drug)
silodosin, arm 2
Experimental
干预措施: silodosin (Drug)
结局指标
主要结局
Spontaneous stone passage rate
时间窗: 4 weeks
次要结局
- Pain severity(4 weeks)
- Time to spontaneous stone passage(4 weeks)
- Analgesic use(4 weeks)
研究者
研究点 (1)
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