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Effect of TU-100 in Patients With Irritable Bowel Syndrome (IBS)

NCT01890837 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-13

No results posted yet for this study

Summary

The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto \[TU-100\] is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.

Conditions

  • Irritable Bowel Syndrome
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Abdominal Pain

Interventions

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 2 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 2 weeks.

Sponsors & Collaborators

  • Cato Research

    collaborator INDUSTRY

  • Tsumura USA

    lead INDUSTRY

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01890837 on ClinicalTrials.gov