A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.

Key facts

Study ID

NCT01388933

Run by

Tsumura USA

People needed

79

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2015-06-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Preferred Research Partners Inc — Little Rock, Arkansas, United States
• TRIMED Clinical Trials — Corona, California, United States
• Digestive Care Associates, LLC — San Carlos, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Rocky Mountain Gastroenterology Associates — Lakewood, Colorado, United States
• Clinical Research of West Florida, Inc — Clearwater, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• University of Chicago Hospital Medical Center — Chicago, Illinois, United States
• University of Louisville School of Medicine — Louisville, Kentucky, United States
• Metropolitan Gastroenterology Group. PC — Chevy Chase, Maryland, United States
• Endoscopic Microsurgery Associates PA — Towson, Maryland, United States
• MedRACS — Quincy, Massachusetts, United States
• Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Digestive Health Center — Ocean Springs, Mississippi, United States
• St. Louis Center for Clinical Research — St Louis, Missouri, United States
• Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
• NY Scientific CORP — Hollis, New York, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
• Ohio Gastroenterology and Liver — Cincinnati, Ohio, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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