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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.

这项建议是对十家临床诊所之一的合作协议(合同)的邀请的回应协作建立、执行、维护和评估多个治疗试验的中心，通过收集和分析信息，顺序或并发地治疗前列腺炎以及来自这种疾病患者的临床样本。长远目标将会透过以下途径达致： 1.通过指导委员会的共同努力，制定议定书(S)和操作手册由临床中心、数据协调中心和NIDDK项目科学家组成。这个临床中心的调查员与数据协调中心一起，将负责在制定议定书方面(S)。 2.招募和接纳符合商定的诊断进入标准的患者进入研究，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每隔一段时间收集的样本将被录取。西北大学提议的临床试验是进行一项前瞻性的多中心随机盲安慰剂试验 SAW Palmetto(SP)或Pygeum African anum(PA)或安慰剂治疗有以下症状的患者的对照试验慢性盆腔疼痛综合征(CPPS)。因为这些药物被广泛用于治疗治疗CPPS和男性下尿路症状，整齐完全缺乏良好表现关于疗效和长期效果的研究，需要一项安慰剂对照试验，其定义为 CPCRN标准。