Clinical trial NCT01388933: A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
natural
herbal
Kampo
inflammatory bowel disease
Adult ages 18 to 75
Male and female subjects
Lead sponsor: Tsumura USA
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2011-07-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical response as measured by a reduction in the CDAI total score
timeFrame: over eight weeks
Secondary outcomes:
measure: CDAI reduction by number of points and difference from baseline
timeFrame: over eight weeks
measure: proportion of subjects showing a clinical remission by measure of CDAI score
timeFrame: over eight weeks
measure: The change in total CDAI score
timeFrame: every four weeks over eight weeks
measure: The change in IBDQ total score and category sub-scores
timeFrame: every four weeks over eight weeks
measure: The change in CRP level
timeFrame: every four weeks over eight weeks
measure: The change in fecal calprotectin levels
timeFrame: over eight weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners Inc
state: Arkansas
city: Corona
country: United States
facility: TRIMED Clinical Trials
state: California
city: San Carlos
country: United States
facility: Digestive Care Associates, LLC
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group. PC
state: Maryland
city: Towson
country: United States
facility: Endoscopic Microsurgery Associates PA
state: Maryland
city: Quincy
country: United States
facility: MedRACS
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Ocean Springs
country: United States
facility: Digestive Health Center
state: Mississippi
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Hollis
country: United States
facility: NY Scientific CORP
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio Gastroenterology and Liver
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Tsumura USA
name: Shunji Mochida, Ph.D.
role: STUDY_DIRECTOR
References: