NCT00583258撤回不适用
A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
研究概览
简要总结
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
- •stone radiopaque on KUB, distal to the sacro-iliac joint
- •patient suitable for discharge from ER
- •patient willing to return for follow-up on a weekly basis for maximum 4 visits
排除标准
- •more than one ureteral calculi
- •radiolucent stones or cystine stones
- •prior ipsilateral calculus or ureteral surgery
- •congenital anomalies of the ureter
- •patients presents with an absolute indication for intervention
- •allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP <90 mmHg)
- •patient currently taking an alpha-blocker
- •hepatic insufficiency
- •pregnancy
研究组 & 干预措施
A
Experimental
干预措施: Alfuzosin (Xatral) (Drug)
B
Placebo Comparator
干预措施: Placebo Alfuzosin (Drug)
结局指标
主要结局
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
时间窗: 4 weeks
次要结局
- Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates(4 weeks)
研究者
研究点 (1)
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