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Crohn's DiseasePhase 2NCT01388933

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

A Phase 2 study testing TU-100 in people with Crohn's Disease, run by Tsumura USA at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
TU-100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
27 sitesUnited States
Study dates
Sep 2011to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • no clinically significant conditions which the doctor would feel exclusionary
  • stable medication (including probiotics)

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • current diagnosis of lactose intolerance
  • history of any other investigational medication within 30 days of enrolling in study
  • unsuitability as determined by the study doctor

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30542-5020

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group. PC

    Chevy Chase, Maryland, 20815

  • University of Chicago Hospital Medical Center

    Chicago, Illinois, 60637

  • Ohio Gastroenterology and Liver

    Cincinnati, Ohio, 45014

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida, Inc

    Clearwater, Florida, 22765

  • TRIMED Clinical Trials

    Corona, California, 92880

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • NY Scientific CORP

    Hollis, New York, 11423

  • Rocky Mountain Gastroenterology Associates

    Lakewood, Colorado, 80215

  • Preferred Research Partners Inc

    Little Rock, Arkansas, 72211

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31210

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Digestive Health Center

    Ocean Springs, Mississippi, 39564

  • Advanced Research Institute

    Ogden, Utah, 84405

  • MedRACS

    Quincy, Massachusetts, 02169

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Digestive Care Associates, LLC

    San Carlos, California, 94070

  • University of California at San Francisco

    San Francisco, California, 94115

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Endoscopic Microsurgery Associates PA

    Towson, Maryland, 21204

  • Center for Digestive Health

    Troy, Michigan, 48098

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

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

Read the detailed description

Crohn's disease, a chronic condition resulting in inflammation of the gastrointestinal tract (GI), causes a person to experience persistent symptoms of inflammatory bowel disease, including abdominal pain, nausea, vomiting, rectal bleeding, diarrhea, and constipation, with infrequent bowel movements that are at times accompanied by a sensation of incomplete emptying after having a bowel movement. Tsumura's TU-100 is a modern herbal product that has been approved as a prescription drug in Japan. Several lines of evidence indicate that TU-100 attenuates intestinal inflammation in Crohn's disease by increasing intestinal blood flow and stimulating a protective lining of intestinal mucus which produces an anti-inflammatory effect. TU-100 may attenuate pathological changes in the intestine and reduce symptoms in patients with Crohn's disease.

Conditions
Crohn's Disease
Being tested
TU-100, Matching Placebo
Keywords
Crohn's Disease, natural, herbal, Kampo, inflammatory bowel disease, Adult ages 18 to 75, Male and female subjects
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TU-100Drug

    Also called Daikenchuto

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

  • Matching PlaceboDrug

    Also called Placebo

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

Study groups in NCT01388933
Study groupRoleWhat they receive
TU-100Experimental15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
Receives: Drug: TU-100
Matching placeboPlacebo comparatorMatching placebo given 5g three times daily orally for 8 consecutive weeks
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: over eight weeks

Secondary outcomes (6)

  1. CDAI reduction by number of points and difference from baseline

    Measured: over eight weeks

  2. proportion of subjects showing a clinical remission by measure of CDAI score

    Measured: over eight weeks

  3. The change in total CDAI score

    Measured: every four weeks over eight weeks

  4. The change in IBDQ total score and category sub-scores

    Measured: every four weeks over eight weeks

  5. The change in CRP level

    Measured: every four weeks over eight weeks

  6. The change in fecal calprotectin levels

    Measured: over eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Why it stopped: Study stopped due to low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01388933
Sponsor's protocol ID
TU100P2T2
Status last verified
May 2015
First submitted
5 Jul 2011
Last updated
11 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TU-100 in people with Crohn's Disease, run by Tsumura USA at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped due to low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response as measured by a reduction in the CDAI total score (time frame: over eight weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01388933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.

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