NCT02074579

A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

A Phase 2, Single-center, Randomized, Double-Blinded, Placebo-Controlled Study on the Efficacy of Daikenchuto (TU 100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily \[TID\]) as compared to placebo on abdominal bloating rating in female IBS patients.

Conditions

• Irritable Bowel Syndrome in Females

Interventions

Type	Name	Description
DRUG	TU-100	15g daily, orally as 5g three times daily for 4 consecutive weeks
DRUG	Placebo	Matching placebo given 5g three times daily orally for 4 consecutive weeks

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-02-28
• Last updated: 2017-05-02

Locations

1 site across 1 country: United States