MEDICAL THERAPY IN BPH--FULL SCALE TRIAL

BPH 的药物治疗——全面试验

• 批准号: 2684264
• 负责人: MANI MENON
• 金额: $ 28.79万
• 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 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2684264
• 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.

本提案概述了我们作为临床中心实施 由良性前列腺增生（BPH）指导委员会制定的方案 前列腺增生症药物治疗临床试验委员会。 议定书 旨在评估有中度和重度症状的男性， 普罗帕酮，随机分为多沙唑嗪组成的4个研究组之一， 非那匹德、多沙唑嗪和非那匹德以及安慰剂。 我们特别 详细说明我们将如何协调招聘，评估，治疗和 在规定的时间内对至少200名患者进行随访。 调查人员不仅在以下方面拥有丰富的经验和专业知识： BPH的临床和流行病学方面，而且在设计中， 开展和实施关于 BPH的药物治疗。 在过去的三年里， HFHS/William博蒙集团已证明有能力成功地 在一项正在进行的多中心NIH U 01合作研究中进行合作。 一个 本研究的目的是与其他临床研究人员充分合作， 中心. 所有所需数据将发送给数据协调 中心和适当的标本将被送往诊断中心 进行适当的处理。 这项研究的另一个目的是及时招募符合条件的 包括少数民族患者在内的代表性患者。 的 亨利福特/博蒙中心吸引了大量的人口， 人口统计数据，包括与大量少数民族建立的关系 人口 在我们正在进行的NIH合作研究中， 少数民族招聘。 在与公共关系的协调下， 营销计划已经制定。 此外，我们还建立了一个 与当地行业的关系，以促进应计利润，并提供独特的 BPH治疗的直接和间接成本的经济数据。 亨利福特/博蒙中心拥有适当的环境， 作为临床中心的物理设施。 临床和 实验室空间，前列腺超声和排尿后残留，以及 可使用复杂的尿动力学设备。 重要经验， 计算机和适当的数据库上建立的系统范围IBM 兼容的网络将确保整个过程中数据收集的一致性 从外围卫星入组、干预和随访 设施