ISRCTN69423238已完成3 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 a blocker (tamsulosin)
niversity of Aberdeen (UK)0 个研究点目标入组 1,200 人开始时间: 2010年11月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients presenting acutely with ureteric colic
- •2. Adults =18 = 65 years of age
- •3. Presence of stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by intravenous urogram (IVU) with subsequent CTKUB confirmation within 12 hours
- •4. Stone within any segment of the ureter
- •5. Unilateral ureteric stone
- •6. Largest stone dimension =10 mm
- •7. 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
- •8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
排除标准
- •1. Women who have a known or suspected pregnancy
- •2. Women who are breastfeeding
- •3. Asymptomatic incidentally found ureteric stone
- •4. Stone not confirmed by CTKUB
- •5. Stone with any one dimension >10 mm
- •6. Kidney stone without the presence of ureteric stone
- •7. Multiple (i.e. = 2) stones within ureter
- •8. Bilateral ureteric stones
- •9. Stone in a ureter draining a solitary kidney (either anatomically or functionally)
- •10. Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit)
- •11. Presence of urinary sepsis
- •12. Chronic renal failure (estinated Glomerular Filtration Rate [eGFR] < 30ml/min)
- •13. Patients currently taking an a blocker
- •14. Patients currently taking a calcium channel blocker
- •15. Patients currently taking PDE5 inhibitors
- •16. Contraindication or allergy to tamsulosin or nifedipine
- •17. Patients who are unable to understand or complete trial documentation
研究者
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