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

Sponsor:	Tsumura USA
Collaborator:	INC Research
Information provided by (Responsible Party):	Tsumura USA
ClinicalTrials.gov Identifier:	NCT01388933

Purpose

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

Condition	Intervention	Phase
Crohn's Disease	Drug: TU-100 Drug: Matching Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Further study details as provided by Tsumura USA:

Primary Outcome Measures:

Clinical response as measured by a reduction in the CDAI total score [ Time Frame: over eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CDAI reduction by number of points and difference from baseline [ Time Frame: over eight weeks ] [ Designated as safety issue: No ]
proportion of subjects showing a clinical remission by measure of CDAI score [ Time Frame: over eight weeks ] [ Designated as safety issue: No ]
The change in total CDAI score [ Time Frame: every four weeks over eight weeks ] [ Designated as safety issue: No ]
The change in IBDQ total score and category sub-scores [ Time Frame: every four weeks over eight weeks ] [ Designated as safety issue: No ]
The change in CRP level [ Time Frame: every four weeks over eight weeks ] [ Designated as safety issue: No ]
The change in fecal calprotectin levels [ Time Frame: over eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2011
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TU-100 15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)	Drug: TU-100 15g daily, orally as 5g three times daily for 8 consecutive weeks Other Names: TU-100 Daikenchuto
Placebo Comparator: Matching placebo Matching placebo given 5g three times daily orally for 8 consecutive weeks	Drug: Matching Placebo 15g as 5g three times daily, orally for 8 consecutive weeks Other Name: Placebo

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388933

Locations

United States, California
Digestive Care Associates, LLC	Recruiting
San Carlos, California, United States, 94070
Contact: Prutha Shah 650-596-8800 studysite@sbcglobal.net
Principal Investigator: Scott D Levenson, MD
University of California at San Francisco	Recruiting
San Francisco, California, United States, 94115
Contact: Yelena Idomsky 415-502-4444 Yelena.Idomsky@ucsfmedctr.org
Principal Investigator: Uma Mahadevan, MD
United States, Colorado
Rocky Mountain Gastroenterology Associates	Recruiting
Lakewood, Colorado, United States, 80215
Contact: James Friend 303-279-1550 james@rockymtncr.com
Principal Investigator: John S Goff, MD
United States, Florida
Gastroenterology Group of Naples	Recruiting
Naples, Florida, United States, 34102
Contact: Lorie Sonstein 239-649-1336 lsonsteinresearch@embarqmail.com
Principal Investigator: Raymond W Phillips, MD
Shafran Gastroenterology Center	Recruiting
Winter Park, Florida, United States, 32789
Contact: Peggy Galvis 407-629-8121 PeggaL7@aol.com
Principal Investigator: Ira Shafran, MD
United States, Georgia
Gastroenterology Associates of Central Georgia	Recruiting
Macon, Georgia, United States, 31210
Contact: Toni Broach 478-464-2600 twilkinson@gaocg.com
Principal Investigator: Shahriar Sedghi, MD
United States, Illinois
University of Chicago Hospital Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Kristi Milam 773-834-8489 kmilam@medicine.bsd.uchicago.edu
Principal Investigator: Stephen B Hanauer, MD
United States, Kentucky
University of Louisville School of Medicine	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Suzanne Mann 502-852-1919 sbmann01@louisville.edu
Principal Investigator: Gerald Dryden, MD
United States, Maryland
Metropolitan Gastroenterology Group. PC	Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Jennifer Bell 301-652-5520 jennifer.bell@capitaldigestivecare.com
Principal Investigator: Robert Hardi, MD
Endoscopic Microsurgery Associates PA	Recruiting
Towson, Maryland, United States, 21204
Contact: Jennifer Hudgins 410-494-1846 jhudgins@gastro-doc.com
Principal Investigator: Mark D Noar, MD
United States, Michigan
Clinical Research Institute of Michigan	Recruiting
Chesterfield, Michigan, United States, 48047
Contact: Aaron Ryder 586-598-3329 aryder@researchmi.com
Principal Investigator: Ronald Fogel, MD
Center for Digestive Health	Recruiting
Troy, Michigan, United States, 48098
Contact: Susan Colar 248-267-8485 scolar@troygastro.com
Principal Investigator: Sante Bologna, MD
United States, Mississippi
Digestive Health Center	Recruiting
Ocean Springs, Mississippi, United States, 39564
Contact: LuAn Brown 228-872-7612 lbrowndhc@yahoo.com
Principal Investigator: Alfred E McNair, MD
United States, Missouri
St. Louis Center for Clinical Research	Recruiting
St. Louis, Missouri, United States, 63128
Contact: Melissa Parker 314-543-5225
Principal Investigator: James W Dimitroff, MD
United States, New York
Long Island Clinical Research Associates, LLP	Recruiting
Great Neck, New York, United States, 11021
Contact: Heather Dufficy 516-466-1051 hdufficy@liclinical.com
Principal Investigator: Seymour Katz, MD
United States, Ohio
Consultants for Clinical Research	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Kim Lyons 513-872-4549 klyons@ccrstudy.com
Principal Investigator: Terrance O'Toole, MD
Ohio Gastroenterology and Liver	Recruiting
Cincinnati, Ohio, United States, 45014
Contact: Deb Gilbert 513-860-4801 dgilbert@ccrstudy.com
Principal Investigator: Terry R Kaylor, MD
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132-2410
Contact: Laura Vinson 801-587-9854 laura.vinson@hsc.utah.edu
Principal Investigator: Kathryn A Peterson, MD

Sponsors and Collaborators

Tsumura USA

INC Research

Investigators

Study Director:

Shunji Mochida, Ph.D.

Tsumura USA

More Information

No publications provided

Responsible Party:	Tsumura USA
ClinicalTrials.gov Identifier:	NCT01388933 History of Changes
Other Study ID Numbers:	TU100P2T2
Study First Received:	July 5, 2011
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tsumura USA:

Crohn's Disease
natural
herbal
Kampo

inflammatory bowel disease
Adult ages 18 to 75
Male and female subjects

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2012