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Chronic Prostatitis Collaborative Research Network

慢性前列腺炎合作研究网络

基本信息

批准号：
7415414
负责人：
ANTHONY J SCHAEFFER
金额：
$ 6.75万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-05 至 2009-02-28
项目状态：
已结题

项目摘要

This proposal is in response to an invitation for a cooperative agreement (contract) for one of ten clinical centers to collaboratively establish, perform, maintain and evaluate multiple therapeutic trials, either sequentially or concurrently for treatments of prostatitis through the collection and analysis of information and clinical samples from patients with the disorder. The long-term objective will be attained by: 1. Developing a protocol(s) and manual of operations through the joint efforts of the Steering Committee consisting of members of the clinical centers, data coordinating center, and the NIDDK project scientist. The investigator from the clinical centers in conjunction with the data coordinating center, will have responsibility in developing the protocol(s). 2. Recruiting and admitting patients into the study who have met agreed upon diagnostic entry criteria, have standard demographic information, symptoms related to prostatitis and who will provide clinical samples collected at established intervals will be enrolled. Northwestern's proposed clinical trial is to conduct a prospective multi-center randomized blinded placebo controlled trial of Saw palmetto (SP) or Pygeum africanum (PA) or placebo in patients with symptoms of chronic pelvic pain syndrome (CPPS). Because of the widespread use of these medications for the treatment of CPPS and lower urinary tract symptoms in men, and the neat total lack of well-performed studies on the efficacy and long-term effects, a placebo controlled trial is needed as defined using the CPCRN criterion.

该提案是为了响应十个临床之一的合作协议（合同）的邀请中心合作建立、执行、维护和评估多项治疗试验，或者通过收集和分析信息，顺序或同时治疗前列腺炎以及来自该疾病患者的临床样本。长期目标将通过以下方式实现： 1. 指导委员会共同制定协议和操作手册由临床中心、数据协调中心和 NIDDK 项目科学家的成员组成。这临床中心的研究者与数据协调中心一起负责制定协议。 2. 招募并接纳符合商定的诊断进入标准的患者进入研究，拥有标准的人口统计信息、与前列腺炎相关的症状以及谁将提供临床信息将登记按规定时间间隔收集的样本。西北大学提出的临床试验是进行一项前瞻性多中心随机盲法安慰剂对有以下症状的患者进行锯棕榈 (SP) 或非洲臀果木 (PA) 或安慰剂的对照试验慢性盆腔疼痛综合征（CPPS）。由于这些药物的广泛使用治疗男性 CPPS 和下尿路症状，并且完全缺乏表现良好的药物关于疗效和长期影响的研究，需要进行安慰剂对照试验，如使用 CPRN 标准。