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TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE

TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE
TAK 603/A 165646 用于克罗恩病患者
批准号：
6263881
负责人：
KIM L ISAACS
金额：
$0.02万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6263881
关键词：
Crohn's disease antirheumatic agents antiulcer drug clinical research drug screening /evaluation gastrointestinal agents gastrointestinal disorder chemotherapy human subject human therapy evaluation immunomodulators quinoline

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中文摘要
翻译
这是一项关于TAK-603/A-165646治疗克罗恩病患者的安全性和有效性的第二阶段研究。这项研究的主要疗效终点将是实现缓解的患者的百分比，定义为CDAI评分150或更低。次要终点将包括症状得到改善的患者的百分比，通过基线CDAI至少减少50个百分点来表示，被归类为治疗失败的患者的百分比，以及医生对疾病活动的全球评估、患者对疾病活动的全球评估、炎症活动的实验室测量和生活质量评估的变化。
英文摘要
This is a Phase II study of the safety and efficacy of TAK-603/A-165646 in patients with crohn's disease. The primary efficacy endpoint of this study will be a percentage of patients achieving remission, defined as a CDAI score of 150 or less. Secondary endpoints will include percentage of patients achieving improvement in symptions, indicated by a reduction in baseline CDAI by at least 50 points, percentage of patients classified as treatment failure, and changes in physicians global assessment of disease activity, patients global assessment of disease activity, laboratory measure of inflammatory activity and qualify of life evaluations.
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会议论文
CLINICAL TRIAL: MULTI-SITE TRIAL OF AZATHIOPRINE DOSING IN CROHN'S DISEASE
MULTI-SITE TRIAL OF AZATHIOPRINE DOSING IN CROHN'S DISEASE
AZATHIOPRINE LOADING TO DECREASE RESPONSE TIME IN CROHN'S DISEASE
TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE
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