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BUDESONIDE CONTROLLED ILEAL RELEASE CAPSULES IN ACTIVE CROHN'S DISEASE

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：
6121128
负责人：
ALAN L. BUCHMAN
金额：
$1.51万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
--
资助国家：
美国
项目状态：
未结题
起止时间：
至
来源：
https://reporter.nih.gov/project-details/6121128
关键词：
Crohn's disease clinical research dosage forms drug screening /evaluation gastrointestinal agents gastrointestinal disorder chemotherapy glucocorticoids human subject human therapy evaluation

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英文摘要
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.
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