Unique ID issued by UMIN | UMIN000009089 |
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Receipt number | R000010660 |
Scientific Title | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TJ-100) in Subjects with Moderate Crohn's Disease |
Date of disclosure of the study information | 2012/11/30 |
Last modified on | 2015/02/17 12:23:47 |
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TJ-100) in Subjects with Moderate Crohn's Disease
A Safety and Efficacy of Daikenchuto in Subjects with Moderate Crohn's Disease
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TJ-100) in Subjects with Moderate Crohn's Disease
A Safety and Efficacy of Daikenchuto in Subjects with Moderate Crohn's Disease
Japan |
Subjects with moderate Crohn's disease (CDAI: 220-300)
Gastroenterology |
Others
NO
Evaluate the induction of a clinical response of moderate Crohn's disease subjects following a total daily oral dose of TJ-100 administered for 8 consecutive weeks.
Safety,Efficacy
The proportion of subjects showing a clinical response, as measured by a 100 point reduction in CDAI total score from baseline (Visit 2) to Visit 4.
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Daikenchuto or placebo (1:1) will be administered orally as 5g three times daily for 8 consecutive weeks. Up to a 14 day screening period (Visit 1) will precede the treatment period (Visits 2 through 4), which lasts 8-weeks.
Daikenchuto or placebo (1:1) will be administered orally as 5g three times daily for 8 consecutive weeks. Up to a 14 day screening period (Visit 1) will precede the treatment period (Visits 2 through 4), which lasts 8-weeks.
18 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Must have Crohn's disease for at least 3 months before the study, confirmed by radiographic, endoscopic, or histological methods.
2) Must have the ability to orally ingest study medication.
3) Be male or female between 18 to 75 years of age.
4) Be diagnosed with Crohn's disease and have a CDAI score of 220-300 points at the time of screening for moderate Crohn's disease.
5) Has no clinically significant deviations in hematologic, hepatic, or renal function parameters as determined by standard laboratory tests, such as liver disorders, kidney disorders, heart failure, blood disorders, or metabolic disorders.
6) If stable doses of the follow medications are taken for at least 4 weeks before screening, the dose must continue through the end of the study: azathioprine, 6-mercaptopurine, methotrexate, 5-aminosalicylates, sulfasalazine, or Crohn's disease -related antibiotics including ciprofloxacin or metronidazole.
Antibiotics for non-Crohn's disease related infections are allowed as long as they are not antibiotics commonly used to treat Crohn's disease.
7) Any probiotics must be taken at a stable dose for 2 weeks prior to randomization and throughout the course of the study.
8) Patients who were explained the study schedule and agreed to participate by their own will, accompanied by written informed consent. When patients are under the age of 20, written informed consent must be obtained by their legal guardians as well as by themselves.
1) History of any bowel condition that may interfere with evaluation of TJ-100, including any bowel resection within 6 months of screening, an extensive bowel resection (>100 cm), short-bowel syndrome, mechanical or uncorrected anatomical bowel obstruction, an ostomy, symptomatic obstructive strictures, a positive stool culture including Clostridium difficile stool assay, or enema therapy within 2-weeks of screening.
2) Female subjects who are pregnant, breastfeeding or planning to become pregnant.
3) History of clinically significant alcohol or drug abuse within a year of screening.
4) Medical history of malignancy within the past 5 years (except for basal or squamous cell carcinoma if the subject is considered recovered).
5) Current diagnosis of ulcerative colitis, scleroderma, Hirschsprung's disease, Chagas disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin -dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation.
6) Current use of any of the following medications: agents with anticholinergic effect; antidepressants are permissible if the subject's symptoms are stable and the doses are not changed during the course of the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics. etc.
120
1st name | |
Middle name | |
Last name | Toshifumi Hibi M.D., Ph.D |
Kitasato Institute Hospital Kitasato University
Center for Advanced IBD Research and Treatment
5-9-1, Shirogane, Minato-ku, Tokyo 108-8642
03-3444-6161
toiawase@insti.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Katsuyoshi Matsuoka |
Keio University, School of Medicine
Division of Gastroenterology & Hepatology
Shinanomachi 35, shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
matsuoka@z2.keio.jp
Keio University, School of Medicine
Tsumura & Co.
Profit organization
Japan
NO
慶應義塾大学病院(東京都)
社会保険中央総合病院 (東京都)
東京医科歯科大学(東京都)
東邦大学医療センター佐倉病院(千葉県)
兵庫医科大学(兵庫県)
福岡大学筑紫病院 (福岡県)
琉球大学医学部附属病院 (沖縄県)
札幌厚生病院 IBDセンター(北海道)
横浜市立大学附属市民総合医療センター 炎症性腸疾患(IBD)センター(神奈川県)
北里大学東病院(東京都)
2012 | Year | 11 | Month | 30 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 10 | Day |
2012 | Year | 12 | Month | 17 | Day |
2014 | Year | 10 | Month | 06 | Day |
2015 | Year | 01 | Month | 28 | Day |
2012 | Year | 10 | Month | 11 | Day |
2015 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010660
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