NCT01890837

Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)

Effect of Daikenchuto (TU-100), a Gastrointestinal Nerve Modulator, on Rectal Sensation in Patients With Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto \[TU-100\] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.

Conditions

• Irritable Bowel Syndrome
• Digestive System Diseases
• Gastrointestinal Diseases
• Intestinal Diseases
• Abdominal Pain

Interventions

Type	Name	Description
DRUG	Daikenchuto (TU-100)	Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
DRUG	Placebo	Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-07-02
• Last updated: 2016-06-13

Locations

1 site across 1 country: United States