drugset / Trial / NCT01139216

Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation

NCT01139216 ↗

Phase 1/2 Completed 45 enrolled Tsumura USA Cato Research · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and small bowel and colonic transit in female patients with functional constipation as compared to placebo.

Timeline

Start
2010-08
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Daikenchuto Traditional medicine (herbal / TCM) 2.5 g Oral
Subject Daikenchuto Traditional medicine (herbal / TCM) 5 g Oral

Indications