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Completed Phase 2 Interventional

Effect of TU-100 in Patients With Functional Constipation

ClinicalTrials.gov ID: NCT01348152

Public ClinicalTrials.gov record NCT01348152. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01348152
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Tsumura USA
Industry
Enrollment
50 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2011
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013
Last update posted
Sep 16, 2013

2011 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Colon and Rectal Surgery Associates Minneapolis Minnesota 55407

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01348152, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 16, 2013 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01348152 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →