A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
研究概览
简要总结
The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age or older
- •Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
- •Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter
排除标准
- •Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
- •History of previous ureteral surgery or ureteral stricture on affected side
- •History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
- •Moderate to severe renal impairment or severe liver insufficiency
- •History of significant postural hypotension
- •Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
- •History of allergy to alpha-blockers or oxycodone
研究组 & 干预措施
silodsosin
干预措施: silodosin (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
时间窗: 4 weeks
The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter.
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
时间窗: 4 weeks
The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.
次要结局
- Time to Spontaneous Stone Passage (All Stones)(4 weeks)
- Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)(4 weeks)
- Time to Spontaneous Stone Passage (Distal Stones)(4 weeks)
- Outpatient Narcotic Analgesic Use for Pain Relief(4 weeks)