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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TU-100
Matching Placebo
Sponsored by
Tsumura USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, natural, herbal, Kampo, inflammatory bowel disease, Adult ages 18 to 75, Male and female subjects

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Preferred Research Partners Inc
  • TRIMED Clinical Trials
  • Digestive Care Associates, LLC
  • University of California at San Francisco
  • Rocky Mountain Gastroenterology Associates
  • Clinical Research of West Florida, Inc
  • Gastroenterology Group of Naples
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Associates, LLC
  • Gastroenterology Associates of Central Georgia
  • University of Chicago Hospital Medical Center
  • University of Louisville School of Medicine
  • Metropolitan Gastroenterology Group. PC
  • Endoscopic Microsurgery Associates PA
  • MedRACS
  • Clinical Research Institute of Michigan
  • Center for Digestive Health
  • Digestive Health Center
  • St. Louis Center for Clinical Research
  • Long Island Clinical Research Associates, LLP
  • NY Scientific CORP
  • PMG Research of Salisbury
  • PMG Research of Winston-Salem, LLC
  • Ohio Gastroenterology and Liver
  • Consultants for Clinical Research
  • Advanced Research Institute
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TU-100

Matching placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CDAI reduction by number of points and difference from baseline
proportion of subjects showing a clinical remission by measure of CDAI score
The change in total CDAI score
The change in IBDQ total score and category sub-scores
The change in CRP level
The change in fecal calprotectin levels

Full Information

First Posted
July 5, 2011
Last Updated
May 18, 2015
Sponsor
Tsumura USA
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT01388933
Brief Title
A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
Official Title
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to low enrollment
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tsumura USA
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, natural, herbal, Kampo, inflammatory bowel disease, Adult ages 18 to 75, Male and female subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TU-100
Arm Type
Experimental
Arm Description
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo given 5g three times daily orally for 8 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
TU-100
Other Intervention Name(s)
Daikenchuto
Intervention Description
15g daily, orally as 5g three times daily for 8 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Placebo
Intervention Description
15g as 5g three times daily, orally for 8 consecutive weeks
Primary Outcome Measure Information:
Title
Clinical response as measured by a reduction in the CDAI total score
Time Frame
over eight weeks
Secondary Outcome Measure Information:
Title
CDAI reduction by number of points and difference from baseline
Time Frame
over eight weeks
Title
proportion of subjects showing a clinical remission by measure of CDAI score
Time Frame
over eight weeks
Title
The change in total CDAI score
Time Frame
every four weeks over eight weeks
Title
The change in IBDQ total score and category sub-scores
Time Frame
every four weeks over eight weeks
Title
The change in CRP level
Time Frame
every four weeks over eight weeks
Title
The change in fecal calprotectin levels
Time Frame
over eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunji Mochida, Ph.D.
Organizational Affiliation
Tsumura USA
Official's Role
Study Director
Facility Information:
Facility Name
Preferred Research Partners Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
TRIMED Clinical Trials
City
Corona
State/Province
California
ZIP/Postal Code
92880
Country
United States
Facility Name
Digestive Care Associates, LLC
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Clinical Research of West Florida, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
22765
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30542-5020
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
University of Chicago Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Louisville School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Metropolitan Gastroenterology Group. PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Endoscopic Microsurgery Associates PA
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
MedRACS
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Digestive Health Center
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NY Scientific CORP
City
Hollis
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio Gastroenterology and Liver
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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