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

May 18, 2015 updated by: Tsumura USA

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners Inc
    • California
      • Corona, California, United States, 92880
        • TRIMED Clinical Trials
      • San Carlos, California, United States, 94070
        • Digestive Care Associates, LLC
      • San Francisco, California, United States, 94115
        • University of California at San Francisco
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Rocky Mountain Gastroenterology Associates
    • Florida
      • Clearwater, Florida, United States, 22765
        • Clinical Research of West Florida, Inc
      • Naples, Florida, United States, 34102
        • Gastroenterology Group of Naples
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30542-5020
        • Atlanta Gastroenterology Associates, LLC
      • Macon, Georgia, United States, 31210
        • Gastroenterology Associates of Central Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group. PC
      • Towson, Maryland, United States, 21204
        • Endoscopic Microsurgery Associates PA
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • MedRACS
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
        • Digestive Health Center
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Hollis, New York, United States, 11423
        • NY Scientific CORP
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cincinnati, Ohio, United States, 45014
        • Ohio Gastroenterology and Liver
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response as measured by a reduction in the CDAI total score
Time Frame: over eight weeks
over eight weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CDAI reduction by number of points and difference from baseline
Time Frame: over eight weeks
over eight weeks
proportion of subjects showing a clinical remission by measure of CDAI score
Time Frame: over eight weeks
over eight weeks
The change in total CDAI score
Time Frame: every four weeks over eight weeks
every four weeks over eight weeks
The change in IBDQ total score and category sub-scores
Time Frame: every four weeks over eight weeks
every four weeks over eight weeks
The change in CRP level
Time Frame: every four weeks over eight weeks
every four weeks over eight weeks
The change in fecal calprotectin levels
Time Frame: over eight weeks
over eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsumura USA

Collaborators

Syneos Health

Investigators

  • Study Director: Shunji Mochida, Ph.D., Tsumura USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU100P2T2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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