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.

该建议是对十个临床之一的合作协议（合同）的邀请以合作建立，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依次或同时处理前列腺炎的治疗以及来自该疾病患者的临床样本。长期目标将通过： 1。通过指导委员会的联合努力制定协议和操作手册由临床中心的成员，数据协调中心和NIDDK项目科学家组成。这临床中心的研究人员与数据协调中心结合在制定协议时。 2。招募并录取已达成同意诊断入境标准的研究患者，具有标准的人口统计信息，与前列腺炎有关的症状，谁将提供临床将在建立时间间隔收集的样本。西北航空提议的临床试验是进行一项前瞻性多中心随机盲人安慰剂患有症状的患者的锯棕榈（SP）或pygeum Africanum（PA）或安慰剂的对照试验慢性骨盆疼痛综合征（CPP）。由于这些药物广泛使用男性的CPP治疗和较低的尿路症状，整洁的总缺乏表现良好关于疗效和长期效果的研究，需要进行安慰剂对照试验。 CPCRN标准。