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

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tsumura USA
• Collaborators: INC Research; Syneos Health

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