NCT01167062Unknown4 期
Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Stone expulsion rate and time.
研究概览
简要总结
This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.
详细描述
- patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
- All patients will receive 75 mg sodium diclofenac via intramuscular on demand
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
- •Male or female patient aged => 18 years.
- •Patients who have distal ureteral stones with a size of 4-10 mm
- •Written informed consent has been obtained.
排除标准
- •Patients with history of ureteral surgery
- •Patients with urinary tract infection
- •Patient with diabetes and peptic ulcer
- •Patient with renal dysfunction (elevated of serum creatinine level)
- •Patients with severe hydronephrosis
- •Patients with history of passing stones
- •Pregnancy
- •Patients who desire to withdraw from the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Tamsulosin Hydrochloride OCAS 0.4 mg
Experimental
干预措施: Tamsulosin Hydrochloride OCAS 0.4 mg (Drug)
结局指标
主要结局
Stone expulsion rate and time.
时间窗: 28 days
次要结局
- Number of diclofenac injection used(28 days)
- Rate of occurrence of adverse events(28 days)
研究者
研究点 (1)
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