适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Safety: General clinical safety by collection of spontaneously reported adverse events
研究概览
简要总结
The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with imagiologic evidence of uretheric stones
排除标准
- •Women pregnant or breast feeding
- •Patients with renal impairment (creatinine > 2mg/dl)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Safety: General clinical safety by collection of spontaneously reported adverse events
时间窗: at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
时间窗: 72h to 96 hours after ESWL
次要结局
- Percentage of patients without imagiologic evidence of any stone(24 hours after ESWL)
- Percentage of patients with clinical evidence of stones clearance(72h to 96 hours after ESWL)
- Time for stone clearance (clinical evaluation)
- Numeric Rating Scale scores(at 24h, (48h, if applicable), 72-96h and 7 days)
- Need for rescue analgesic medication.
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Alfuzosin in Uretheric Stones - ALF-STONEEUCTR2005-005481-36-PTSanofi-Synthelabo Produtos Farmaceuticos, S.A.220
已完成
3 期
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral CalculiKidney CalculiColicUreteral CalculiNCT00177086University of Minnesota76
已完成
3 期
Alfuzosin Hydrochloride to Relieve Ureteral Stent DiscomfortUreteral Stent DiscomfortNCT00467467University of Minnesota60
已完成
3 期
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder DysfunctionNeurogenic Urinary BladderNCT00549939Sanofi172
撤回
3 期
Use of Alfuzosin in Stone Treatment With ESWLUrinary CalculiNCT00388271Singapore General Hospital