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Terminated Phase 2 Interventional

A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease

ClinicalTrials.gov ID: NCT01388933

Public ClinicalTrials.gov record NCT01388933. 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 3, 2026, 1:55 AM 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 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

Brief summary

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

The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.

Study identification

NCT ID
NCT01388933
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Tsumura USA
Industry
Enrollment
79 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 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
Aug 31, 2013
Completion
Aug 31, 2013
Last update posted
Jun 10, 2015

2011 – 2013

United States locations

U.S. sites
27
U.S. states
17
U.S. cities
26
Facility City State ZIP Site status
Preferred Research Partners Inc Little Rock Arkansas 72211
TRIMED Clinical Trials Corona California 92880
Digestive Care Associates, LLC San Carlos California 94070
University of California at San Francisco San Francisco California 94115
Rocky Mountain Gastroenterology Associates Lakewood Colorado 80215
Clinical Research of West Florida, Inc Clearwater Florida 22765
Gastroenterology Group of Naples Naples Florida 34102
Shafran Gastroenterology Center Winter Park Florida 32789
Atlanta Gastroenterology Associates, LLC Atlanta Georgia 30542-5020
Gastroenterology Associates of Central Georgia Macon Georgia 31210
University of Chicago Hospital Medical Center Chicago Illinois 60637
University of Louisville School of Medicine Louisville Kentucky 40202
Metropolitan Gastroenterology Group. PC Chevy Chase Maryland 20815
Endoscopic Microsurgery Associates PA Towson Maryland 21204
MedRACS Quincy Massachusetts 02169
Clinical Research Institute of Michigan Chesterfield Michigan 48047
Center for Digestive Health Troy Michigan 48098
Digestive Health Center Ocean Springs Mississippi 39564
St. Louis Center for Clinical Research St Louis Missouri 63128
Long Island Clinical Research Associates, LLP Great Neck New York 11021
NY Scientific CORP Hollis New York 11423
PMG Research of Salisbury Salisbury North Carolina 28144
PMG Research of Winston-Salem, LLC Winston-Salem North Carolina 27103
Ohio Gastroenterology and Liver Cincinnati Ohio 45014
Consultants for Clinical Research Cincinnati Ohio 45219
Advanced Research Institute Ogden Utah 84405
University of Washington Medical Center Seattle Washington 98195

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01388933, 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 Jun 10, 2015 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01388933 live on ClinicalTrials.gov.

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