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

NCT02074579 ↗

Phase 2 Completed 101 enrolled Tsumura USA ICON Clinical Research · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2014-07
Primary completion: 2016-04
Completion: 2016-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TU-100	Traditional medicine (herbal / TCM)	5 g	Oral

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

Summary

Timeline

Drugs

Indications