MEDICAL THERAPY IN BPH--FULL SCALE TRIAL

BPH 的药物治疗——全面试验

• 批准号: 6380991
• 负责人: MANI MENON
• 金额: $ 25.31万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-04-27 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6380991
• 关键词: alpha antiadrenergic agent; benign prostate hyperplasia; clinical trials; cooperative study; finasteride; human subject; human therapy evaluation; male; reproductive system disorder chemotherapy; reproductive system pharmacology

This proposal outlines our plan as a Clinical Center to implement the protocol developed by the Benign Prostatic Hyperplasia (BPH) steering committee for the clinical trial of medical therapy in BPH. The protocol is designed to evaluate men with moderate and severe symptoms of prostatism, randomized into one of 4 study arms consisting of doxazosin, finasteride, doxazosin and finasteride, and placebo. Specifically, we detail how we will coordinate efforts to recruit, evaluate, treat and follow up at least 200 patients in the time frame required. The investigators have extensive experience and expertise not only in the clinical and epidemiological aspects of BPH, but also in the design, conduct and implementation of collaborative clinical trials on the pharmacologic treatment of BPH. Over the pst three years, the HFHS/William Beaumont group has demonstrated the ability to successfully collaborate in an ongoing multicenter NIH U01 cooperative study. An objective of this study is to collaborate fully with other Clinical Centers. All the required data will be sent to the Data Coordinating Center and the appropriate specimens will be sent to the Diagnostic Center for proper processing. Another objective of this study is the timely recruitment of eligible patients including a representative number of minority patients. The Henry Ford/Beaumont Centers draw from a large population with unique demographics including an established relationship with a large minority population. In our ongoing NIH collaborative study we are leading in minority recruitment. In concert with public relations an intensive marketing plan has been developed. Additionally, we have established a relationship with local industry to promote accrual and to provide unique economic data on the direct and indirect costs of BPH treatment. The Henry Ford/Beaumont Center has the appropriate environment and physical facilities to perform as a clinical center. The clinical and laboratory space, ultrasound for prostate and post void residual, and complex urodynamic equipment are available. Significance experience with computers and appropriate data bases on an established system wide IBM compatible network will ensure consistent data collection throughout enrollment, intervention and follow up from the peripheral satellite facilities.

该提案概述了我们作为临床中心的计划 由良性前列腺增生（BPH）转向开发的协议 BPH医疗治疗临床试验委员会。 协议 旨在评估患有中度和严重症状的男性 前列性，随机分为由多克萨斯辛组成的4个研究臂之一， 非那雄胺，多克萨斯素和非那雄胺以及安慰剂。 具体来说，我们 详细说明我们将如何协调招募，评估，治疗和 在需要的时间范围内跟踪至少200名患者。 调查人员不仅具有丰富的经验和专业知识 BPH的临床和流行病学方面，但在设计中也 进行和实施协作临床试验 BPH的药理学治疗。 在PST三年中， HFHS/William Beaumont Group已证明了成功的能力 在正在进行的多中心NIH U01合作研究中合作。 一个 这项研究的目的是与其他临床完全合作 中心。 所有必需的数据将发送到数据协调 中心和适当的标本将发送到诊断中心 用于适当的处理。 这项研究的另一个目的是及时招募合格 包括代表性少数患者的患者。 这 亨利·福特（Henry Ford）/博蒙特中心（Beaumont Centers）从大量人口中汲取独特 人口统计学包括与少数族裔建立的关系 人口。 在我们正在进行的NIH合作研究中，我们领导 少数民族招募。 与公共关系一致 营销计划已经制定。 此外，我们已经建立了 与当地行业的关系以促进应计并提供独特的关系 关于BPH治疗的直接和间接成本的经济数据。 亨利·福特/博蒙特中心有适当的环境， 作为临床中心的物理设施。 临床和 实验室空间，前列腺超声和空隙后残留物，以及 提供复杂的尿动力设备。 意义经验 计算机和适当的数据基础在已建立的系统宽IBM上 兼容网络将确保整个数据收集一致 从外围卫星入学，干预和跟进 设施。