Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01388933
Status:
TERMINATED
Last Update Posted:
2015-06-11
First Post:
2011-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559645', 'term': '12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine'}, {'id': 'C121414', 'term': 'dai-kenchu-to'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'whyStopped': 'Study stopped due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2015-05-18', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2011-07-05', 'dispFirstSubmitQcDate': '2015-05-18', 'studyFirstSubmitQcDate': '2011-07-05', 'dispFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response as measured by a reduction in the CDAI total score', 'timeFrame': 'over eight weeks'}], 'secondaryOutcomes': [{'measure': 'CDAI reduction by number of points and difference from baseline', 'timeFrame': 'over eight weeks'}, {'measure': 'proportion of subjects showing a clinical remission by measure of CDAI score', 'timeFrame': 'over eight weeks'}, {'measure': 'The change in total CDAI score', 'timeFrame': 'every four weeks over eight weeks'}, {'measure': 'The change in IBDQ total score and category sub-scores', 'timeFrame': 'every four weeks over eight weeks'}, {'measure': 'The change in CRP level', 'timeFrame': 'every four weeks over eight weeks'}, {'measure': 'The change in fecal calprotectin levels', 'timeFrame': 'over eight weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'natural', 'herbal', 'Kampo', 'inflammatory bowel disease', 'Adult ages 18 to 75', 'Male and female subjects'], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* provide written informed consent\n* ability to orally ingest study medication\n* male or female between 18 to 75 inclusive\n* diagnosed with Crohn's disease for at least 3 months\n* CDAI score of 220-300 at screening\n* sexually active participants of childbearing potential must agree to birth control\n* no clinically significant conditions which the doctor would feel exclusionary\n* stable medication (including probiotics)\n\nExclusion Criteria:\n\n* history of any bowel condition that may interfere with the evaluation of the study drug\n* positive stool cultures\n* currently pregnant or lactating\n* receiving total parenteral nutrition\n* history of alcohol or drug abuse within one year\n* history of malignancy within 5 years\n* current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics\n* treatment with Anti-TNF agents 12 weeks before screening\n* treatment with corticosteroids four weeks prior to screening\n* treatment with cyclosporine or tacrolimus eight weeks prior to screening\n* presence of a poorly controlled medical condition\n* history of allergic reaction to ginseng, ginger or sichuan pepper\n* any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial\n* 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)\n* history of celiac disease\n* current diagnosis of lactose intolerance\n* history of any other investigational medication within 30 days of enrolling in study\n* unsuitability as determined by the study doctor"}, 'identificationModule': {'nctId': 'NCT01388933', 'briefTitle': "A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Tsumura USA'}, 'officialTitle': "A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease", 'orgStudyIdInfo': {'id': 'TU100P2T2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TU-100', 'description': '15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)', 'interventionNames': ['Drug: TU-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'description': 'Matching placebo given 5g three times daily orally for 8 consecutive weeks', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'TU-100', 'type': 'DRUG', 'otherNames': ['Daikenchuto'], 'description': '15g daily, orally as 5g three times daily for 8 consecutive weeks', 'armGroupLabels': ['TU-100']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '15g as 5g three times daily, orally for 8 consecutive weeks', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners Inc', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92880', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'TRIMED Clinical Trials', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '94070', 'city': 'San Carlos', 'state': 'California', 'country': 'United States', 'facility': 'Digestive Care Associates, LLC', 'geoPoint': {'lat': 37.50716, 'lon': -122.26052}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80215', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Gastroenterology Associates', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '22765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastroenterology Group of Naples', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Shafran Gastroenterology Center', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30542-5020', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gastroenterology Associates, LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Central Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospital Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville School of Medicine', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Metropolitan Gastroenterology Group. PC', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Endoscopic Microsurgery Associates PA', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MedRACS', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Institute of Michigan', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Digestive Health', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '39564', 'city': 'Ocean Springs', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Digestive Health Center', 'geoPoint': {'lat': 30.41131, 'lon': -88.82781}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Center for Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Clinical Research Associates, LLP', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11423', 'city': 'Hollis', 'state': 'New York', 'country': 'United States', 'facility': 'NY Scientific CORP', 'geoPoint': {'lat': 40.71344, 'lon': -73.76708}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Salisbury', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Winston-Salem, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45014', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Gastroenterology and Liver', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Consultants for Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Research Institute', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Shunji Mochida, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tsumura USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tsumura USA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}