PHASE II MULTIPLE-DOSE SAFETY & EFFICACY STUDY OF A SELE

II 期多次剂量安全性

• 批准号: 2879697
• 负责人: PATRICK M. LYNCH
• 金额: $ 47.24万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2879697
• 关键词: biomarker; cancer prevention; chemoprevention; clinical research; colorectal neoplasms; drug administration rate /duration; drug screening /evaluation; family genetics; genetic carriers; histopathology; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer genetics; nonsteroidal antiinflammatory agent; oxidoreductase inhibitor; prostaglandin endoperoxide synthase

This is a randomized, double-blind placebo-controlled pharmacologic intervention trial in HNPCC patients and carriers (with or without prior clinical manifestations). The study arms are: 1) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #1 p.o. BID, 2) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #2 p.o. BID, and 3) placebo. There will be 18 patients randomized to each of the arms. The study drugs will be given for twelve months (365+/- 10 days). Assessment of endoscopic, histopathologic, and cellular endpoints will be conducted at baseline, three, and twelve months on study drug or placebo. Safety monitoring will occur via in- patient interviews with exams at months three and twelve; blood and UA's at months one, three, six, nine, and twelve; and via telephone interviews at monthly (at weeks two and four of month one) intervals. A post- administration telephone call to evaluate side effect resolution will occur at month 14, in those with side effects at termination. A parallel project involving approximately 20 subjects will be conducted at another NCI-designated site; NCI will coordinate the efforts and activities of both sites.

这是一种随机、双盲、安慰剂对照的药理学 对HNPCC患者和携带者的干预试验(有或没有事先 临床表现)。研究臂为：1)环氧合酶-2(COX-2) 抑制剂或非甾体抗炎药，剂量#1，P.O.2)环氧合酶-2(COX-2) 抑制剂或非甾体抗炎药，剂量#2，P.O.出价，以及3)安慰剂。将会有18个 病人被随机分配到每一只手臂上。研究药物将用于 12个月(365+/-10天)。内窥镜检查、组织病理学检查、 蜂窝终端将在基线、三点和十二点进行 研究药物或安慰剂几个月。安全监控将通过以下方式进行- 患者在3个月和12个月时进行检查；血液和尿酸 在一、三、六、九和十二个月时；并通过电话采访 每月一次(第一个月的第二周和第四周)。一篇帖子- 政府拨打电话评估副作用解决方案将 发生在第14个月，在终止时有副作用的患者。一个平行的 涉及大约20个学科的项目将在另一个 NCI指定的地点；NCI将协调以下工作和活动 两个网站都有。