MedTrace Logo

A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

NCT02074579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2017-05-02

No results posted yet for this study

Summary

The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily \[TID\]) as compared to placebo on abdominal bloating rating in female IBS patients.

Conditions

  • Irritable Bowel Syndrome in Females

Interventions

DRUG

TU-100

15g daily, orally as 5g three times daily for 4 consecutive weeks

DRUG

Placebo

Matching placebo given 5g three times daily orally for 4 consecutive weeks

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Tsumura USA

    lead INDUSTRY

Principal Investigators

  • Kirsten Tillisch, MD · Oppenheimer Family Center of Neurobiology of Stress, UCLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02074579 on ClinicalTrials.gov