NCT01388933

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

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	TU-100	15g daily, orally as 5g three times daily for 8 consecutive weeks
DRUG	Matching Placebo	15g as 5g three times daily, orally for 8 consecutive weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-07-07
• Last updated: 2015-06-11

Locations

27 sites across 1 country: United States