UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009089
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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