NCT01139216

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

Effect of DAIKENCHUTO (TU-100), a Gastrointestinal Nerve Modulator, on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Female Patients With Functional Constipation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Constipation
• Gastric Emptying
• Whole Gut Transit
• Small Bowel Transit
• Colonic Transit
• Rectal Compliance
• Rectal Sensation

Interventions

Type	Name	Description
DRUG	Daikenchuto (TU-100)	Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
DRUG	Daikenchuto (TU-100)	Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
DRUG	Placebo	Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-06-08
• Last updated: 2013-01-14

Locations

1 site across 1 country: United States