MULTICENTER DOUBLE BLIND PLACEBO CONTROLLED STUDY TO EVALUATE AND COMPARE

多中心双盲安慰剂对照研究的评估和比较

• 批准号: 6291013
• 负责人: D CRAIG BRATER
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6291013
• 关键词: clearance rate; clinical research; clinical trials; creatinine; dosage; drug screening /evaluation; human old age (65+); human subject; indomethacin; kidney function; nonsteroidal antiinflammatory agent; placebos; prostaglandin endoperoxide synthase; protein isoforms

Nonsteroidal anti-inflammatory drugs (NSAIDs) are on of the most widely prescribed class of medications. While generally safe, this class of medications may be associated with serious gastrointestinal and renal adverse effects, both there efficacy and toxicity is attributed to the inhibition of cyclo-oxygenase (COX). Cyclo-oxygenase has recently been discovered to exist in two isoforms COX-1 which is involved in maintenance prostaglandins and COX-2 which is involved in the production of inflammatory prostaglandins. Currently available nonsteroidal anti- inflammatory drugs (NSAIDs) have been characterized as dual COX-1 and COX-2 inhibitors [1,2]. This is a double-blind, placebo-controlled, multicenter, double-dummy, parallel group study to evaluate and compare the effects of multiple doses of the selective COX-2 inhibitor MK-0966, indomethacin, and placebo on renal function in subjects 65 to 80 year of age with creatinine clearance 30 to 80 ml/minute.

非甾体抗炎药（NSAID）是最广泛的 处方类药物。 虽然一般来说是安全的，但这类 药物可能与严重的胃肠道和肾脏疾病有关。 不良反应，无论是功效还是毒性都归因于 抑制环氧合酶（考克斯）。 环氧合酶最近被 发现存在两种亚型考克斯-1，参与维持 参与产生的考克斯-2 炎性类胡萝卜素。 目前可用的非甾体抗- 炎性药物（NSAID）已被表征为双重考克斯-1， 考克斯-2抑制剂[1，2]。 这是一个双盲安慰剂对照 多中心、双模拟、平行组研究，以评价和比较 多剂量选择性考克斯-2抑制剂MK-0966的作用， 吲哚美辛和安慰剂对65 - 80岁老年人肾功能影响 肌酐清除率30 - 80 ml/min的年龄。