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

NCT01388933 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2015-06-11

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

TU-100

15g daily, orally as 5g three times daily for 8 consecutive weeks

DRUG

Matching Placebo

15g as 5g three times daily, orally for 8 consecutive weeks

Sponsors & Collaborators

Principal Investigators

  • Shunji Mochida, Ph.D. · Tsumura USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01388933 on ClinicalTrials.gov