A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
2015年5月18日 更新者：Tsumura USA
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
研究概览
详细说明
Crohn's disease, a chronic condition resulting in inflammation of the gastrointestinal tract (GI), causes a person to experience persistent symptoms of inflammatory bowel disease, including abdominal pain, nausea, vomiting, rectal bleeding, diarrhea, and constipation, with infrequent bowel movements that are at times accompanied by a sensation of incomplete emptying after having a bowel movement.
Tsumura's TU-100 is a modern herbal product that has been approved as a prescription drug in Japan.
Several lines of evidence indicate that TU-100 attenuates intestinal inflammation in Crohn's disease by increasing intestinal blood flow and stimulating a protective lining of intestinal mucus which produces an anti-inflammatory effect.
TU-100 may attenuate pathological changes in the intestine and reduce symptoms in patients with Crohn's disease.
研究类型
介入性
注册 (实际的)
79
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72211
- Preferred Research Partners Inc
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California
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Corona、California、美国、92880
- TRIMED Clinical Trials
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San Carlos、California、美国、94070
- Digestive Care Associates, LLC
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San Francisco、California、美国、94115
- University of California at San Francisco
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Colorado
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Lakewood、Colorado、美国、80215
- Rocky Mountain Gastroenterology Associates
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Florida
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Clearwater、Florida、美国、22765
- Clinical Research of West Florida, Inc
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Naples、Florida、美国、34102
- Gastroenterology Group Of Naples
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Winter Park、Florida、美国、32789
- Shafran Gastroenterology Center
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Georgia
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Atlanta、Georgia、美国、30542-5020
- Atlanta Gastroenterology Associates, LLC
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Macon、Georgia、美国、31210
- Gastroenterology Associates of Central Georgia
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago Hospital Medical Center
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville School of Medicine
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Maryland
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Chevy Chase、Maryland、美国、20815
- Metropolitan Gastroenterology Group. PC
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Towson、Maryland、美国、21204
- Endoscopic Microsurgery Associates PA
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Massachusetts
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Quincy、Massachusetts、美国、02169
- MedRACS
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Michigan
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Chesterfield、Michigan、美国、48047
- Clinical Research Institute of Michigan
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Troy、Michigan、美国、48098
- Center for Digestive Health
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Mississippi
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Ocean Springs、Mississippi、美国、39564
- Digestive Health Center
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Missouri
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St. Louis、Missouri、美国、63128
- St. Louis Center for Clinical Research
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New York
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Great Neck、New York、美国、11021
- Long Island Clinical Research Associates, LLP
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Hollis、New York、美国、11423
- NY Scientific CORP
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North Carolina
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Salisbury、North Carolina、美国、28144
- PMG Research of Salisbury
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Winston-Salem、North Carolina、美国、27103
- PMG Research of Winston-Salem, LLC
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Ohio
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Cincinnati、Ohio、美国、45219
- Consultants for Clinical Research
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Cincinnati、Ohio、美国、45014
- Ohio Gastroenterology and Liver
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Utah
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Ogden、Utah、美国、84405
- Advanced Research Institute
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Washington
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Seattle、Washington、美国、98195
- University of Washington Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- provide written informed consent
- ability to orally ingest study medication
- male or female between 18 to 75 inclusive
- diagnosed with Crohn's disease for at least 3 months
- CDAI score of 220-300 at screening
- sexually active participants of childbearing potential must agree to birth control
- no clinically significant conditions which the doctor would feel exclusionary
- stable medication (including probiotics)
Exclusion Criteria:
- history of any bowel condition that may interfere with the evaluation of the study drug
- positive stool cultures
- currently pregnant or lactating
- receiving total parenteral nutrition
- history of alcohol or drug abuse within one year
- history of malignancy within 5 years
- current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics
- treatment with Anti-TNF agents 12 weeks before screening
- treatment with corticosteroids four weeks prior to screening
- treatment with cyclosporine or tacrolimus eight weeks prior to screening
- presence of a poorly controlled medical condition
- history of allergic reaction to ginseng, ginger or sichuan pepper
- any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial
- current use of any of the following herbal medications: Boswellia, Cat's claw (Uncaria tomentosa), Cayenne pepper, Echinacea, Horsetail (Equisetum), Hops, Lady's mantle (Alchemilla), Marshmallow root (Althaea), Slippery elm (Ulmus rubra) Turmeric and White Willow (Salix alba)
- history of celiac disease
- current diagnosis of lactose intolerance
- history of any other investigational medication within 30 days of enrolling in study
- unsuitability as determined by the study doctor
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
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15g daily, orally as 5g three times daily for 8 consecutive weeks
其他名称：
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安慰剂比较：Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
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15g as 5g three times daily, orally for 8 consecutive weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Clinical response as measured by a reduction in the CDAI total score
大体时间：over eight weeks
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over eight weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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CDAI reduction by number of points and difference from baseline
大体时间：over eight weeks
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over eight weeks
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proportion of subjects showing a clinical remission by measure of CDAI score
大体时间：over eight weeks
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over eight weeks
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The change in total CDAI score
大体时间：every four weeks over eight weeks
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every four weeks over eight weeks
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The change in IBDQ total score and category sub-scores
大体时间：every four weeks over eight weeks
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every four weeks over eight weeks
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The change in CRP level
大体时间：every four weeks over eight weeks
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every four weeks over eight weeks
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The change in fecal calprotectin levels
大体时间：over eight weeks
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over eight weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (实际的)
2013年9月1日
研究完成 (实际的)
2013年9月1日
研究注册日期
首次提交
2011年7月5日
首先提交符合 QC 标准的
2011年7月5日
首次发布 (估计)
2011年7月7日
研究记录更新
最后更新发布 (估计)
2015年6月11日
上次提交的符合 QC 标准的更新
2015年5月18日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
TU-100的临床试验
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Tsumura USACato Research完全的
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Plotnikoff, Gregory A., M.D.University of Minnesota; Tsumura and Company, Tokyo, Japan完全的