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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01388933
• Other study ID #: TU100P2T2
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2011
• Last updated: May 18, 2015
• Start date: September 2011
• Est. completion date: September 2013

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Tsumura USA	INC Research

Country where clinical trial is conducted

United States, 

Outcome

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