A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
NCT ID: NCT01388933
Last Updated: 2015-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2011-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Interventions
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TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Tsumura USA
INDUSTRY
Responsible Party
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Principal Investigators
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Shunji Mochida, Ph.D.
Role: STUDY_DIRECTOR
Tsumura USA
Locations
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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
Advanced Research Institute
Ogden, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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TU100P2T2
Identifier Type: -
Identifier Source: org_study_id
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