BUDESONIDE CONTROLLED ILEAL RELEASE CAPSULES IN ACTIVE CROHN'S DISEASE

布地奈德控制回肠释放胶囊治疗活动性克罗恩病

• 批准号: 6281698
• 负责人: ALAN L. BUCHMAN
• 金额: $ 1.36万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6281698
• 关键词: Crohn's disease; clinical research; dosage forms; drug screening /evaluation; gastrointestinal agents; gastrointestinal disorder chemotherapy; glucocorticoids; human subject; human therapy evaluation

The aim of this study is to assess the efficacy and safety of budesonide compared to placebo in patients with active Crohn's disease affecting the ileum and/or the ascending colon. Approximately 200 patients nationwide will be randomized to 4.5 or 9 mg controlled ileal release capsules once or twice a day, or placebo. Budesonide is a glucocortisosteroid with high topical antiinflammatory activity and significant first-pass metablism. The primary efficacy variable will be the Crohn's Disease Activity Index remission rate.

本研究的目的是评估布地奈德的疗效和安全性 与安慰剂相比，在活动性克罗恩病患者中， 回肠和/或升结肠。 全国约200名患者 将随机分配至4.5或9 mg回肠控释胶囊组， 或者一天两次，或者安慰剂 布地奈德是一种糖皮质激素， 局部抗炎活性和显著的首过代谢。 主要疗效变量为克罗恩病活动指数 缓解率