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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003103
Receipt No. R000003761
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer (a randomized, double-blind, multi-center, placebo-controlled study)
Date of disclosure of the study information 2010/02/01
Last modified on 2014/04/24

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Basic information
Public title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC40-1001)
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
Scientific Title:Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC40-1001)
Region
Japan

Condition
Condition Primary or metastatic liver cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for accompanying abdominal symptoms (abdominal bloating, etc.) in intestinal dysmotility following resection of liver cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 1) Time to first defecation after nasogastric tube removal (hr)
2) Postoperative number of bowel movements per day
3) blood ammonia level(micro gram/dL)
4) CRP(mg/dL)
Key secondary outcomes 1) QOL assessment by the GSRS Score (Japanese Version)
2) ICG-R15(%)
3) Incidence of postoperative intestinal obstruction
4) Incidence of postoperative complications
5) postoperative length of stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.
Interventions/Control_2 Oral administration of test drug (placebo)5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) PS(ECOG Performance Status Scale):0-2
2) Patients who is able to have oral intake of the test drugs
3) Age: 20 years or older
4) Gender: no specification
5) 4weeks or more blank after therapy is needed in case of receiving chemotherapy or radiotherapy in the prior treatment
6) Adequate organ functions and operable patient
7) CRP <= 2mg/dL
8) Inpatient/Outpatient: Inpatient(study duration)
9) Patients who can provide written informed consent
Key exclusion criteria 1) Patients who are scheduled to undergo laparoscopic hepatectomy
2) Patients with history of hepatectomy
3) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case)
4) Patients requiring emergency surgery
5) Patients with synchronous or metachronous gastric resection
6) Patients with synchronous colon resection
7) RFA in the remnant liver at the same time as excising hepatectomy
8) Patients with history of chemotherapy or radiotherapy within4weeks before surgery , history of perioperative chemotherapy or radiotherapy
9) Patients who are scheduled to undergo chemotherapy or radiotherapy within 10days after surgery
10) Patients who are administered another Kanpo medicines for medical treatment within 4weeks before the test drug administration
11) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
12) Patients undergoing biliary reconstruction
13) Patients who have a colostomy
14) Patients with history of resection of digestive canal
15) Constitutional selective defect in the hepatic transport of indocyanine green (ICG) ;Patients who are ICG intolerant
16) Synbiotics combination
17) Others, patients who are unfit for the study as determined by the attending physician
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Kusano
Organization Non-Profit Organization (NPO); Japan Labour Health and Welfare Organization
Division name KUSHIRO ROSAI HOSPITAL
Zip code
Address 13-23, Nakazono-cho, Kushiro, Hokkaido 085-8533, Japan
TEL 0154-25-7308
Email

Public contact
Name of contact person
1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
Zip code
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization Non profit foundation
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 北海道大学病院(北海道),札幌医科大学附属病院(北海道),釧路労災病院(北海道),弘前大学附属病院(青森県),岩手医科大学附属病院(岩手県),東北大学病院(宮城県),日立総合病院(茨城県),深谷赤十字病院(埼玉県),亀田総合病院(千葉県),君津中央病院(千葉県),東邦大学医療センター大森病院(東京都),慶應義塾大学病院(東京都),東京医科大学八王子医療センター(東京都),富山大学病院(富山県),藤田保健衛生大学(愛知県),藤田保健衛生大学坂文種報徳會病院(愛知県)京都大学附属病院(京都府),大阪府立成人病センター(大阪府),大阪市立大学附属病院(大阪府),大阪府立急性期・総合医療センター(大阪府),大阪大学(大阪府),大阪医科大学(大阪府),大阪南医療センター(大阪府),徳島大学(徳島県),九州大学病院(福岡県),飯塚病院(福岡県),久留米大学病院(福岡県),長崎大学(長崎県),熊本大学附属病院(熊本県),大分大学附属病院(大分県),鹿児島大学附属病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1007/s10147-014-0678-2
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
2010 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 27 Day
Last modified on
2014 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003761

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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