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

NCT01388933 | Terminated Phase 2

• 1 other identifier: TU100P2T2
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

Crohn's Disease

Keywords

Crohn's Disease; natural; herbal; Kampo; inflammatory bowel disease; Adult ages 18 to 75; Male and female subjects

Outcome Measures

Primary Outcomes (1)

• Clinical response as measured by a reduction in the CDAI total score

  over eight weeks

Secondary Outcomes (6)

• CDAI reduction by number of points and difference from baseline

  over eight weeks

• proportion of subjects showing a clinical remission by measure of CDAI score

  over eight weeks

• The change in total CDAI score

  every four weeks over eight weeks

• The change in IBDQ total score and category sub-scores

  every four weeks over eight weeks

• The change in CRP level

  every four weeks over eight weeks

Study Arms (2)

TU-100

EXPERIMENTAL

15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)

Drug: TU-100

Matching placebo

PLACEBO COMPARATOR

Matching placebo given 5g three times daily orally for 8 consecutive weeks

Drug: Matching Placebo

Interventions

TU-100 DRUG

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

Also known as: Daikenchuto

TU-100

Matching Placebo DRUG

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

Also known as: Placebo

Matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provide written informed consent
• ability to orally ingest study medication
• male or female between 18 to 75 inclusive
• diagnosed with Crohn's disease for at least 3 months
• CDAI score of 220-300 at screening
• sexually active participants of childbearing potential must agree to birth control
• stable medication (including probiotics)

You may not qualify if:

• history of any bowel condition that may interfere with the evaluation of the study drug
• positive stool cultures
• currently pregnant or lactating
• receiving total parenteral nutrition
• history of alcohol or drug abuse within one year
• history of malignancy within 5 years
• current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics
• treatment with Anti-TNF agents 12 weeks before screening
• treatment with corticosteroids four weeks prior to screening
• treatment with cyclosporine or tacrolimus eight weeks prior to screening
• presence of a poorly controlled medical condition
• history of allergic reaction to ginseng, ginger or sichuan pepper
• any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial
• current use of any of the following herbal medications: Boswellia, Cat's claw (Uncaria tomentosa), Cayenne pepper, Echinacea, Horsetail (Equisetum), Hops, Lady's mantle (Alchemilla), Marshmallow root (Althaea), Slippery elm (Ulmus rubra) Turmeric and White Willow (Salix alba)
• history of celiac disease

Sponsors & Collaborators

• Tsumura USA: lead
• Syneos Health: collaborator

Study Sites (27)

Preferred Research Partners Inc

Little Rock, Arkansas, 72211, United States

Location

TRIMED Clinical Trials

Corona, California, 92880, United States

Location

Digestive Care Associates, LLC

San Carlos, California, 94070, United States

Location

University of California at San Francisco

San Francisco, California, 94115, United States

Location

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, 80215, United States

Location

Clinical Research of West Florida, Inc

Clearwater, Florida, 22765, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30542-5020, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31210, United States

Location

University of Chicago Hospital Medical Center

Chicago, Illinois, 60637, United States

Location

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Metropolitan Gastroenterology Group. PC

Chevy Chase, Maryland, 20815, United States

Location

Endoscopic Microsurgery Associates PA

Towson, Maryland, 21204, United States

Location

MedRACS

Quincy, Massachusetts, 02169, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Digestive Health Center

Ocean Springs, Mississippi, 39564, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

NY Scientific CORP

Hollis, New York, 11423, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Ohio Gastroenterology and Liver

Cincinnati, Ohio, 45014, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine; dai-kenchu-to

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Shunji Mochida, Ph.D.

  Tsumura USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 11, 2015

Record last verified: 2015-05

Locations

US (27)