Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Stone-free rate at 14th day of study
研究概览
简要总结
This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.
详细描述
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Enrollment
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patients with ureteral stones of sizes from 3 to 10 mm
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patients aged more than 18 years
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Randomization
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naftopidil 75 mg qd for 14 days or placebo
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Standard treatment with pain-killers were also applied.(aceclofenac)
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Follow-up for 28 days
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We confirm the stone free status by CT or X-ray films at 14th and 28th days.
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Rates of active treatment will be also evaluated.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 20 years
- •single 3 to 10 mm ureter stone (longest diameter)
排除标准
- •Presence of multiple ureter stones
- •Renal insufficiency (serum Cr > 1.4 mg/dL)
- •Febrile urinary tract infections(fever > 38°C, evidence of urinary infection)
- •pregnancy or breast feeding
- •solitary kidney
- •hypersensitivity to naftopidil
- •current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
- •moderate or severe cardiovascular or cerebrovascular disease
- •hepatic dysfunction (>2 x normal upper limit)
- •significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- •Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption
研究组 & 干预措施
Control groups with only analgesics
Control groups will receive only analgesics.
干预措施: Placebo for Naftopidil (Drug)
Control groups with only analgesics
Control groups will receive only analgesics.
干预措施: Standard treatment (Drug)
Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
干预措施: Naftopidil 75mg (Drug)
Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
干预措施: Standard treatment (Drug)
结局指标
主要结局
Stone-free rate at 14th day of study
时间窗: 14th day
Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone)
次要结局
- Duration to stone passage within 28days of study(for 28 days)
- Stone-free rate at 28th day of study(28th day)
- amount of analgesics used for 28 days of study(for 28 days)
- Rate of active treatment(for 28 days)
研究者
Chang Wook Jeong
M.D, Ph.D.
Seoul National University Hospital