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

This study is currently recruiting participants.
Verified April 2013 by Tsumura USA
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Tsumura USA
ClinicalTrials.gov Identifier:
NCT01388933
First received: July 5, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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:

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: August 2013
Estimated Primary Completion Date: August 2013 (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

  Show 28 Study Locations
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: April 9, 2013
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 22, 2013