drugset / Trial / NCT01348152

Effect of TU-100 in Patients With Functional Constipation

NCT01348152 ↗

Phase 2 Completed 50 enrolled Tsumura USA Cato Research · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score \[1\], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.

Timeline

Start
2011-09
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Daikenchuto Traditional medicine (herbal / TCM) 15 g Oral

Indications