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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009089
Receipt No. 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

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Basic information
Public title A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TJ-100) in Subjects with Moderate Crohn's Disease
Acronym A Safety and Efficacy of Daikenchuto in Subjects with Moderate Crohn's Disease
Scientific Title A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TJ-100) in Subjects with Moderate Crohn's Disease
Scientific Title:Acronym A Safety and Efficacy of Daikenchuto in Subjects with Moderate Crohn's Disease
Region
Japan

Condition
Condition Subjects with moderate Crohn's disease (CDAI: 220-300)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Hibi M.D., Ph.D
Organization Kitasato Institute Hospital Kitasato University
Division name Center for Advanced IBD Research and Treatment
Zip code
Address 5-9-1, Shirogane, Minato-ku, Tokyo 108-8642
TEL 03-3444-6161
Email toiawase@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyoshi Matsuoka
Organization Keio University, School of Medicine
Division name Division of Gastroenterology & Hepatology
Zip code
Address Shinanomachi 35, shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email matsuoka@z2.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Tsumura & Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 17 Day
Last follow-up date
2014 Year 10 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 01 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 11 Day
Last modified on
2015 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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