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

Tsumura

Status and phase

Terminated

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Matching Placebo

Drug: TU-100

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01388933

TU100P2T2

Details and patient eligibility

About

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

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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