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

This study has been terminated.
(Study stopped due to low enrollment)
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Tsumura USA
ClinicalTrials.gov Identifier:
NCT01388933
First received: July 5, 2011
Last updated: April 18, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 79
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 27 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 18, 2014
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 September 29, 2014