Planning a multi-center trial of tamsulosin for urolithiasis

计划开展坦索罗辛治疗尿石症的多中心试验

• 批准号: 8049530
• 负责人: JEREMY BROWN
• 金额: $ 38.22万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8049530
• 关键词: Planning; multi; center; trial; tamsulosin

DESCRIPTION (provided by applicant): Project Summary Urolithiasis is a disease that affects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients. Based on encouraging results from several small European clinical studies, it appears that the administration of tamsulosin to patients with symptomatic urolithiasis enhances stone passage, and reduces both the time to recovery and the need for surgical intervention or lithotripsy. A pilot study was carried out at The George Washington University that enrolled 109 patients. This study demonstrated that we could enroll patients in the setting of the emergency department, and achieve high rates of follow-up. In order to determine the efficacy of tamsulosin we need to enroll approximately 500 patients, and in order to do this we plan a multicenter study. This Planning grant will be used to plan and prepare for the multicenter study, During the planning phase the following steps will be completed: a) Finalize final study protocol; b) Finalize manual of procedures; c) Develop consent forms; d) Develop and the test on-line data entry tool; e) Develop the data monitoring and management plan; f) Develop a plan for the acquisition and administration of study drug & placebo; g) Develop a safety oversight plan; h) Develop a detailed budget for conduct and completion of the clinical trial; i) Develop training materials and training for study staff; j) Initiate training of study coordinators at new clinical study sites; k) Submit for IRB approval; l) Initiate training of all ED clinical staff at new clinical study sites m) Submission of the U01 multicenter study proposal. If we can study the therapeutic benefit of tamsulosin, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis. PUBLIC HEALTH RELEVANCE: Project Narrative This grant will support the planning of a multicenter study to test if tamsulosin helps patients with painful kidney stones. There is no current medical treatment for kidney stones, but some small trials have shown a benefit from tamsulosin. We will plan a large clinical trial that can determine if there is indeed any benefit from this medicine to treat this painful condition, a condition that sends over one million people to the emergency department each year.

描述（由申请人提供）： 项目摘要 尿石症是一种影响 12% 人口的疾病，并且其发病率正在上升。在美国，每年有超过 110 万人次因肾绞痛前往急诊室就诊。这种疾病极其痛苦，通常需要大量麻醉镇痛，并导致工作日损失。此外，多达 30% 的患者最终可能需要碎石术或手术切除结石。目前，除了镇痛之外，没有向患者提供任何医疗干预措施。根据欧洲几项小型临床研究的令人鼓舞的结果，对有症状的尿石症患者服用坦索罗辛似乎可以促进结石排出，并减少恢复时间和手术干预或碎石术的需要。乔治华盛顿大学开展了一项试点研究，招募了 109 名患者。这项研究表明，我们可以在急诊室招募患者，并实现高随访率。为了确定坦索罗辛的疗效，我们需要招募大约 500 名患者，为此我们计划进行一项多中心研究。该规划拨款将用于规划和准备多中心研究，在规划阶段将完成以下步骤： a) 敲定最终研究方案； b) 完成程序手册； c) 制定同意书； d) 开发并测试在线数据录入工具； e) 制定数据监控和管理计划； f) 制定研究药物和安慰剂的获取和管理计划； g) 制定安全监督计划； h) 为临床试验的进行和完成制定详细的预算； i) 为研究人员开发培训材料和培训； j) 在新的临床研究中心启动研究协调员的培训； k) 提交IRB批准； l) 在新的临床研究中心启动对所有急诊科临床工作人员的培训 m) 提交 U01 多中心研究提案。如果我们能够研究坦索罗辛的治疗效果，这将代表尿石症治疗的重大进展。这一目标是 NIDDK 临床泌尿外科项目的一个主要既定目标，该项目的既定使命是改善尿石症的治疗。 公共卫生相关性：项目叙述 这笔赠款将支持一项多中心研究的规划，以测试坦索罗辛是否可以帮助患有痛苦的肾结石的患者。目前尚无治疗肾结石的药物，但一些小型试验表明坦索罗辛有一定的益处。我们将计划进行一项大型临床试验，以确定这种药物是否确实对治疗这种痛苦的疾病有任何益​​处，这种疾病每年将超过一百万人送往急诊室。