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）：项目摘要尿石病是一种影响人口12％且其发病率正在增长的疾病。在美国，每年有超过110万次访问临床部门的肾绞痛。该疾病极为痛苦，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岩石术或手术去除石头。目前，除了镇痛以外，没有其他医疗干预措施提供给患者。基于几项欧洲小型临床研究的令人鼓舞的结果，看来对有症状的尿石病患者的Tamsulosin可以增强石材通道，并减少了恢复的时间以及进行手术干预或刻板疗法的需求。在乔治华盛顿大学进行了一项试点研究，招募了109名患者。这项研究表明，我们可以将患者纳入急诊室的环境，并实现高度随访。为了确定Tamsulosin的功效，我们需要注册约500名患者，为此，我们计划了一项多中心研究。该计划赠款将用于计划和准备多中心研究，在计划阶段，将完成以下步骤：a）最终确定最终研究协议； b）最终确定程序手册； c）制定同意书； d）开发和测试在线数据输入工具； e）制定数据监视和管理计划； f）制定一项计划，以获取和管理研究药物和安慰剂； g）制定安全监督计划； h）制定详细的预算，以进行临床试验的行为和完成； i）为学习人员开发培训材料和培训； j）在新的临床研究地点启动研究协调员的培训； k）提交IRB批准； l）在新的临床研究网站上启动所有ED临床人员的培训m）提交U01多中心研究建议。如果我们可以研究Tamsulosin的治疗益处，那将代表尿石病治疗的重大进步。该目标是NIDDK临床泌尿外科计划的主要既定目标，该计划具有改善尿石病治疗的任务。 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计划，以测试Tamsulosin是否帮助患有疼痛肾结石的患者。目前尚无针对肾结石的医疗，但是一些小型试验显示出Tamsulosin受益。我们将计划一项大型临床试验，该试验可以确定这种药物是否确实有任何好处来治疗这种痛苦状况，这种疾病每年将超过一百万人带到急诊室。