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: 6291139
• 负责人: D CRAIG BRATER
• 金额: $ 0.04万
• 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/6291139
• 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 the 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. 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.

非甾体类抗炎药（NSAIDS）是最广泛规定的药物类别。 虽然通常是安全的，但这种类型的药物可能与严重的胃肠道和肾脏不良反应有关，但功效和毒性都归因于环氧酶（COX）的抑制。 最近已经发现，环氧合酶存在于两个同工型COX-1中，该同工型COX-1与维持前列腺素和COX-2有关，该酶与炎性前列腺素的生产有关。 当前，可用的非甾体抗炎性药物（NSAID）已被视为双COX-1和COX-2抑制剂。 这是一项双盲，安慰剂对照，多中心，双人，平行组研究，可评估和比较多剂量的选择性COX-2抑制剂MK-0966，吲哚美辛，安慰剂和安慰剂对65至80岁受试者肾功能的影响与Creatinine Clearce 30至80 ml/分钟。