Continuing Application for the Data Coordinating Center for (CAMUS) Trial (U01)

描述（由申请方提供）：CAMUS是一项随机、双盲、两组试验，共有369名良性前列腺增生（BPH）受试者，在72周内大致平均分配至Serenoa repens（锯棕榈）提取物或安慰剂组，剂量递增，连续3个24周，从320 mg开始，然后是640 mg，然后是960 mg每日一次。受试者继续接受研究治疗，直至符合方案规定的治疗中止原因或完成72周治疗期。11家CAMUS临床中心于2008年6月5日开始招募，并于2009年4月17日成功完成369例受试者的随机化。这是一份继续资助CAMUS数据协调中心（DCC）的申请，以确保完成所有参与者的后续工作，数据收集输入和管理以及结果的准备和发布。本延续申请的具体目的是：1.完成CAMUS方案规定的治疗、随访和关闭活动2。准备最终数据集，3。完成计划的出版物，包括最终结果和基于最终试验数据集的其他论文DCC在本持续申请期间的作用包括，在本资助期内预计额外8000页数据的数据输入;数据编辑，查询生成和最终分析数据集的创建，以及数据字典和缺失数据报告;协调和召开执行委员会、指导委员会、小组委员会和研究协调员会议;编写DSMB和IND报告，分析数据，为CAMUS编写摘要、手稿和演示文稿。 公共卫生相关性：Serenoa Repens（sawpalmetto）是一种广泛用于治疗BPH的非处方药。到目前为止，还没有证据表明它在治疗BPH方面的有效性。如果它确实有效地减少下尿路症状，它可能会受到许多男性的青睐，基于“自然疗法”的吸引力，其有利的副作用，以及相对于BPH处方药的成本。

DESCRIPTION (provided by applicant): CAMUS is a randomized, double-blind, two arm trial with 369 participants with Benign Prostatic Hyperplasia (BPH), approximately equally allocated to either the Serenoa repens (saw palmetto) extract or placebo over a 72 week period in escalating doses over three consecutive 24 weeks periods, beginning with 320 mg, then 640 mg, and then 960 mg daily . Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. The 11 CAMUS clinical centers initiated recruitment June 5, 2008 and successfully completed randomization of 369 subjects on April 17, 2009. This is an application for continued funding for the Data Coordinating Center (DCC) for CAMUS to ensure that follow up of all participants, data collection entry and management and preparation and publication of results is completed. Specific Aims for this continuation application are to: 1. Complete CAMUS the protocol-specified treatment, follow-up and close out activities 2. Prepare the final dataset, and 3. Complete planned publications, including final results and other papers based on the final trial dataset The DCC's role in this during the period of this continued application includes, data entry for the additional 8000 page equivalents of data expected in this funding period; data editing, query generation and creation of a final analysis data set with a data dictionary and missing data report; coordination and conduct of Executive Committee, Steering Committee, sub-committee and study coordinator meetings; preparation of DSMB and IND reports and the analysis of data and preparation of abstracts, manuscripts and presentations for CAMUS. PUBLIC HEALTH RELEVANCE: Serenoa Repens (sawpalmetto) is a widely used over the counter agent in the treatment of BPH. So far there is no evidence of its effectiveness in the treatment of BPH. If it is indeed effective at reducing lower urinary tract symptoms, it may well be preferred by many men based on the "natural therapy" appeal, its favorable side-effect profile, and its cost, relative to the prescription medications for BPH.