EUCTR2010-019469-26-GB进行中（未招募）1 期
se of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre placebo controlled randomised trial of a calcium channel blocker(nifedipine)and an alpha blocker(tamsulosin) - The SUSPEND trial - Symptomatic ureteric stone passage enabled by drugs (SUSPEND)
niversity of Aberdeen0 个研究点目标入组 1,167 人开始时间: 2010年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,167
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients presenting acutely with ureteric colic
- •Adults =18 to = 65 years of age
- •Presence of stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by IVU (intravenous urogram) with subsequent CTKUB confirmation within 12 hours
- •Stone within any segment of the ureter
- •Unilateral ureteric stone
- •Largest dimension of the stone =10 mm
- •Female subjects must be post menopausal (defined as 12 months with no menses without an alternative medical cause), permanently sterilised or willing to use two methods of contraception listed in the protocol prior to the start of dosing until at least 28 days after receiving the last dose of trial medication
- •Capable of giving written informed consent, which includes compliance with the requirements of the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women who have a known or suspected pregnancy (confirmed by a pregnancy test)
- •Women who are breast-feeding
- •Asymptomatic incidentally found ureteric stone
- •Stone not confirmed by CTKUB
- •Stone with any one dimension >10 mm
- •Kidney stone without the presence of ureteric stone
- •Multiple (i.e. = 2) stones within ureter
- •Bilateral ureteric stones
- •Stone in a ureter draining a solitary kidney (either anatomically or functionally)
- •Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit)
- •Presence of urinary sepsis
- •Chronic kidney disease renal failure stage 4 or stage 5 (eGFR < 30ml/min)
- •Patients currently taking an a-blocker
- •Patients currently taking a calcium channel blocker
- •Patients currently taking PDE5 inhibitors
- •Contraindication or allergy to tamsulosin or nifedipine
- •Patients who are unable to understand or complete trial documentation
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