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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01388933
• Date of registration: 05/07/2011
• Prospective Registration: Yes
• Primary sponsor: Tsumura USA
• Public title: A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
• Scientific title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
• Date of first enrolment: September 2011
• Target sample size: 79
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01388933
• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Shunji Mochida, Ph.D.
• Affiliation: Tsumura USA

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Matching Placebo

Drug: TU-100

Primary Outcome(s)

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

Secondary Outcome(s)

The change in fecal calprotectin levels [Time Frame: over eight weeks]

proportion of subjects showing a clinical remission by measure of CDAI score [Time Frame: over eight weeks]

The change in CRP level [Time Frame: every four weeks over eight weeks]

The change in IBDQ total score and category sub-scores [Time Frame: every four weeks over eight weeks]

The change in total CDAI score [Time Frame: every four weeks over eight weeks]

CDAI reduction by number of points and difference from baseline [Time Frame: over eight weeks]

Secondary ID(s)

TU100P2T2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

INC Research