Chronic Prostatitis Collaborative Research Network

慢性前列腺炎合作研究网络

• 批准号: 6684671
• 负责人: ANTHONY J SCHAEFFER
• 金额: $ 25万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-05 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6684671
• 关键词: alternative medicine; chronic disease /disorder; clinical research; clinical trials; cooperative study; disease /disorder etiology; human subject; interstitial cystitis; male; male reproductive system disorder diagnosis; pain; pathologic process; patient oriented research; pelvis; plant extracts; prostatitis; reproductive system disorder chemotherapy; reproductive system pharmacology; saw palmetto; urinary tract disorder chemotherapy

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 该提案是对十个临床中心之一的合作协议（合同）的邀请，以通过收集和分析患者的信息和分析来建立，执行，维护和评估多种治疗试验，以依次或同时治疗前列腺炎的治疗。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手册，该委员会由临床中心，数据协调中心和NIDDK项目科学家组成。临床中心的研究人员与数据协调中心结合使用，将有责任制定协议。 2。招募并允许接受达成一致的诊断入境标准的患者，具有标准的人口统计信息，与前列腺炎有关的症状以及将在既定时间间隔内提供临床样本的症状。 西北航空提出的临床试验是在患有慢性盆腔疼痛综合征（CPP）症状的患者中，对SAW Palmetto（SP）或Pygeum Africanum（PA）或安慰剂（PA）或安慰剂进行前瞻性多中心随机盲型安慰剂对照试验。由于这些药物广泛用于治疗CPP和男性尿路症状较低，并且完全缺乏对功效和长期效果的良好性研究，因此需要使用CPCRN标准来定义安慰剂对照试验。