NCT01348152

Effect of TU-100 in Patients With Functional Constipation

A Randomized, Double-Blinded, Placebo-Controlled Exploratory Study of Daikenchuto (TU-100) in Patients With Functional Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	DAIKENCHUTO (TU-100)	Subjects will be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days.
DRUG	Placebo	Subjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-05-05
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States