Crohn's Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
Verified date | May 2015 |
Source | Tsumura USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
Status | Terminated |
Enrollment | 79 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia |
United States | Clinical Research Institute of Michigan | Chesterfield | Michigan |
United States | Metropolitan Gastroenterology Group. PC | Chevy Chase | Maryland |
United States | University of Chicago Hospital Medical Center | Chicago | Illinois |
United States | Consultants for Clinical Research | Cincinnati | Ohio |
United States | Ohio Gastroenterology and Liver | Cincinnati | Ohio |
United States | Clinical Research of West Florida, Inc | Clearwater | Florida |
United States | TRIMED Clinical Trials | Corona | California |
United States | Long Island Clinical Research Associates, LLP | Great Neck | New York |
United States | NY Scientific CORP | Hollis | New York |
United States | Rocky Mountain Gastroenterology Associates | Lakewood | Colorado |
United States | Preferred Research Partners Inc | Little Rock | Arkansas |
United States | University of Louisville School of Medicine | Louisville | Kentucky |
United States | Gastroenterology Associates of Central Georgia | Macon | Georgia |
United States | Gastroenterology Group of Naples | Naples | Florida |
United States | Digestive Health Center | Ocean Springs | Mississippi |
United States | Advanced Research Institute | Ogden | Utah |
United States | MedRACS | Quincy | Massachusetts |
United States | PMG Research of Salisbury | Salisbury | North Carolina |
United States | Digestive Care Associates, LLC | San Carlos | California |
United States | University of California at San Francisco | San Francisco | California |
United States | University of Washington Medical Center | Seattle | Washington |
United States | St. Louis Center for Clinical Research | St. Louis | Missouri |
United States | Endoscopic Microsurgery Associates PA | Towson | Maryland |
United States | Center for Digestive Health | Troy | Michigan |
United States | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina |
United States | Shafran Gastroenterology Center | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Tsumura USA | INC Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response as measured by a reduction in the CDAI total score | over eight weeks | No | |
Secondary | CDAI reduction by number of points and difference from baseline | over eight weeks | No | |
Secondary | proportion of subjects showing a clinical remission by measure of CDAI score | over eight weeks | No | |
Secondary | The change in total CDAI score | every four weeks over eight weeks | No | |
Secondary | The change in IBDQ total score and category sub-scores | every four weeks over eight weeks | No | |
Secondary | The change in CRP level | every four weeks over eight weeks | No | |
Secondary | The change in fecal calprotectin levels | over eight weeks | No |
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