NCT00177086已完成3 期
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Spontaneous stone passage for distal ureteral calculi
研究概览
简要总结
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.
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 (Participant, Investigator)
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
- •Age =>18
- •<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram
排除标准
- •Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
- •Pregnant/Nursing females
- •Solitary kidney
- •Renal insufficiency (Creatinine>1.8)
- •Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
- •Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C)
- •Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased
- •Other alpha-blockers
- •Phosphodiesterase type 5 inhibitors for erectile dysfunction
- •Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study
结局指标
主要结局
Spontaneous stone passage for distal ureteral calculi
时间窗: increased
次要结局
- Decrease the pain and narcotic use associated with stone passage(decrease)
- Decrease the time to spontaneous passage(decrease)
- Shift the size distribution of stones passed towards larger sizes
研究者
研究点 (2)
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