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）： 本提案是为了响应10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有该疾病的患者的信息和临床样本，合作建立，执行，维护和评估多个治疗试验，顺序或同时进行前列腺炎的治疗。将通过以下方式实现长期目标： 1.通过指导委员会的共同努力制定方案和操作手册，指导委员会由临床中心、数据协调中心和NIDDK项目科学家的成员组成。临床中心的研究者将与数据协调中心一起负责制定方案。 2.招募和接收符合商定的诊断入选标准、具有标准人口统计学信息、前列腺炎相关症状且将提供在确定时间间隔采集的临床样本的患者入组研究。 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照试验锯棕榈（SP）或Pygeum africanum（PA）或安慰剂在慢性盆腔疼痛综合征（CPPS）症状的患者。由于这些药物广泛用于治疗男性CPPS和下尿路症状，并且完全缺乏关于疗效和长期效果的良好研究，因此需要使用CPCRN标准定义的安慰剂对照试验。