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Effect of TU-100 in Patients With Functional Constipation

NCT01348152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-09-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cato Research

    collaborator INDUSTRY

  • Tsumura USA

    lead INDUSTRY

Principal Investigators

  • Anders F Mellgren, MD, PhD · Colon and Rectal Surgery Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348152 on ClinicalTrials.gov