Chronic Prostatitis Collaborative Research Network

慢性前列腺炎合作研究网络

• 批准号: 7235697
• 负责人: ANTHONY J SCHAEFFER
• 金额: $ 23.7万
• 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 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7235697
• 关键词: Blinded; Chronic Prostatitis; Clinical; Clinical Investigator; Clinical Trials; Collection; Contracts; Data Coordinating Center; Diagnostic; Disease; Enrollment; Joints; Long-Term Effects; Manuals; National Institute of Diabetes and Digestive and Kidney Diseases; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Placebos; Protocols documentation; Prunus africana; Randomized; Recruitment Activity; Research; Sabal serrulata; Sampling; Scientist; Standards of Weights and Measures; Symptoms; Therapy Clinical Trials; U-Series Cooperative Agreements; chronic pelvic pain; lower urinary tract symptoms; member; men; placebo controlled study; prospective; prostatitis; response

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)： 这项建议是对十个临床中心之一的一项合作协议(合同)的邀请的回应，该中心将通过收集和分析前列腺炎患者的信息和临床样本，以顺序或同时的方式合作建立、执行、维持和评估多项治疗试验。长远目标将会透过以下途径达致： 1.由临床中心、数据协调中心和NIDDK项目科学家组成的指导委员会共同努力，制定规程(S)和操作手册。临床中心的调查员将与数据协调中心一起负责制定方案(S)。 2.招募和接纳符合商定的诊断进入标准、具有标准人口学信息、与前列腺炎有关的症状以及将提供按既定间隔收集的临床样本的患者将被纳入研究。 西北大学提议的临床试验是对有慢性盆腔疼痛综合征(CPPS)症状的患者进行一项前瞻性的多中心随机安慰剂对照试验，试验对象为锯棕榈(SP)或非洲鬼臼(PA)或安慰剂。由于这些药物在男性中广泛用于治疗CPPS和下尿路症状，而完全缺乏关于疗效和长期效果的良好研究，因此需要一项使用CPCRN标准定义的安慰剂对照试验。