MEDICAL THERAPY FOR BPH--DATA COORDINATING CENTER

BPH 的药物治疗--数据协调中心

• 批准号: 2145702
• 负责人: RAYMOND P BAIN
• 金额: $ 114.42万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2145702
• 关键词: alpha antiadrenergic agent; androgen inhibitor; benign prostate hyperplasia; clinical trials; cooperative study; data collection methodology /evaluation; human subject; human therapy evaluation; male; reproductive system disorder chemotherapy; statistical service /center; technical writing

The Biostatistics Center of The George Washington University proposes to work in cooperative agreement with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK-NIH) to serve as the Data Coordinating Center (DCC) for a proposed multi-center clinical trial of the medical therapy of benign prostatic hyperplasia (BPH). the purpose of the NIH-BPH Clinical Trial is to determine the safety and efficacy of the pharmacotherapies finasteride (an inhibitor of 5-alpha-reductase) and doxazosin (a blocker of alpha-1 adrenoreceptors) on the clinical progression of BPH. The objective of the transition phase is to finalize the protocol, operations manual and data collection forms to be implemented in a 6 year full-scale clinical trial. The trial will require randomization of 2,800 participants with a diagnosis of BPH over a 2 year period in 17 clinical centers. Eligible participants will be randomly assigned, double-masked, to one of four treatment groups: (1) active finasteride (5 mg., once per day) and active doxazosin (4 mg or 8 mg, once per day); (2) active finasteride and doxazosin placebo; (3) finasteride placebo and active doxazosin; or (4) finasteride placebo and doxazosin placebo. Randomized participants will be followed for a minimum of 4 years (maximum of 6 years) with quarterly follow-up visits. Clinical progression of BPH is defined by the incidence of acute urinary retention, renal insufficiency, recurrent urinary tract infections, incontinence, or a pre-specified increase in the American Urological Association (AUA) symptom score. Secondary outcomes include differences over time among the four treatment groups with respect to AUA symptom score Quality of Life and maximal uroflow. Tissue biopsies will be obtained in 20 percent of the participants to provide information on the histopathobiology of BPH and to test existing biomarkers for their prognostic ability regarding response to medical therapy. The specific aims of the DCC are to provide centralized support and biostatistical consultation in the transition of the pilot study's patient management protocols, operations manual, data collection forms and randomization procedures to the full-scale clinical trial; implementation of a data processing system including data quality assessment; interim analysis of protocol performance, patient safety and treatment efficacy; ad final analysis for publication of the NIH-BPH Clinical Trial results in collaboration with the clinical investigators.

乔治华盛顿大学的生物统计中心建议， 与美国国立糖尿病研究所合作 和消化和肾脏疾病（NIDDK-NIH）作为数据 协调中心（DCC），用于拟定的多中心临床试验， 良性前列腺增生（BPH）的药物治疗。目的 NIH-BPH临床试验的目的是确定 药物治疗芬那肽（5-α-还原酶的抑制剂）和 多沙唑嗪（α-1肾上腺素受体阻滞剂）对临床 BPH的进展。 过渡阶段的目标是最后确定议定书， 操作手册和数据收集表将在6年内实施 全面的临床试验该试验将需要2，800名随机化 在17个临床研究中， 中心.合格的受试者将随机分配，双盲， 四个治疗组之一：（1）活性芬特（5 mg，一次 每日一次）和活性多沙唑嗪（4 mg或8 mg，每日一次）;（2）活性 非那肽和多沙唑嗪安慰剂;（3）非那肽安慰剂和活性药物 多沙唑嗪;或（4）非那肽安慰剂和多沙唑嗪安慰剂。随机 参与者将被随访至少4年（最多6年 年），每季度进行一次随访。BPH的临床进展 由急性尿潴留，肾功能不全， 复发性尿路感染、尿失禁或预先指定的 美国泌尿外科协会（AUA）症状评分增加。 次要结果包括四种治疗方法随时间的差异。 AUA症状评分、生活质量和最大 尿流将在20%的患者中进行组织活检。 与会者提供有关BPH组织生物学的信息， 测试现有生物标志物的预后能力， 对药物治疗的反应。 发展协调委员会的具体目标是提供集中支助， 在试点研究过渡期间进行生物统计咨询 患者管理方案、操作手册、数据收集表 和全规模临床试验的随机化程序; 包括数据质量的数据处理系统的实现 评估;方案性能、患者安全性和 治疗疗效; NIH-BPH发表的最终分析 与临床研究者合作得出临床试验结果。