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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001592
Receipt No. R000001912
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study)
Date of disclosure of the study information 2009/01/01
Last modified on 2015/05/18

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Basic information
Public title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC39-0902)
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Scientific Title:Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC39-0902)
Region
Japan

Condition
Condition Colon cancer including RS 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 ethical use for accompanying abdominal symptoms (abdominal pain, bloating, etc.)in intestinal dysmotility following laparotomy for colon 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 (hr) after nasogastric tube removal
2)Postoperative frequency of defecation (number of times/day)
3)Postoperative stool form (Bristol Stool Form Scale)
Key secondary outcomes 1) GSRS Score
2) FACT-C Score
3) CRP
4) Incidence of postoperative intestinal
obstruction

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.
May decrease dosage to 7.5g/day (2.5g/pack x 3 packs) according to patient`s symptoms.
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.
May decrease dosage to 7.5g/day (2.5g/pack x 3 packs) according to patient`s symptoms.
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) Patients who qualify for curative colonic resection (solely via laparotomy) for colon cancer (including rectosigmoidal region)
Preoperative staging of disease: I, II, IIIa, IIIb
TNM category distribution: T=1-3, N=0-2, M=0
2) PS (ECOG Performance Status Scale): 0, 1
3) Patients who can orally administration of Daikenchuto
4) Age: over 20 yo.
5) Gender: no specification
6) Inpatient/Outpatient: Inpatient
7) Patients who can provide written informed consent
Key exclusion criteria 1) Patients with a history of endoscopic surgery
2) Patients with a history of laparoscopic surgery
3) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn disease)
4) Patients requiring emergency surgery
5) Patients with double cancer
6) Patients with serious liver disorder
7) Patients with serious renal disorder
8) Patients with history of laparotomy and peritonitis (excludes surgery for appendicitis)
9) Patients who are taking other Kampo formulation(s)
10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
11) Others, including patients who are unfit for the study as determined by the attending physician
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University
Division name School of Medicine. Department of Surgery
Zip code
Address 1-15-1, kitasato,Sagamihara,Kanagawa,228-8555,Japan
TEL 042-778-8735
Email gekaw@med.kitasato-u.ac.jp

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 旭川医科大学(北海道),小樽掖済会病院(北海道),東北大学(宮城県),福島県立医科大学(福島県),栃木県立がんセンター(栃木県),国際医療福祉大学病院(栃木県),群馬大学(群馬県),埼玉県立がんセンター(埼玉県),獨協医科大学越谷病院(埼玉県),君津中央病院(千葉県),帝京大学ちば総合医療センター(千葉県),東京慈恵会医科大学(東京都),日本医科大学(東京都),東邦大学医療センター大森病院(東京都),日本赤十字社医療センター(東京都),慶應義塾大学(東京都),帝京大学(東京都),杏林大学(東京都),町田市民病院(東京都),国際医療福祉大学三田病院(東京都),東急病院(東京都),けいゆう病院(神奈川県),北里大学(神奈川県),北里大学東病院(神奈川県),横浜市立大学(神奈川県),新潟大学(新潟県),富山大学(富山県),金沢赤十字病院(石川県),岐阜大学(岐阜県),岐阜県総合医療センター(岐阜県),木沢記念病院(岐阜県),浜松医科大学(静岡県),藤田保健衛生大学(愛知県),大津赤十字病院(滋賀県),西陣病院(京都府),宇治徳洲会病院(京都府),医仁会武田総合病院(京都府),大阪大学(大阪府),関西医科大学枚方病院(大阪府),大阪南医療センター(大阪府),広島市立安佐市民病院(広島県),広島大学(広島県),中国中央病院(広島県),山口大学(山口県),徳島大学(徳島県),香川中央病院(香川県),高知大学(高知県),九州大学(福岡県),長崎大学(長崎県),熊本大学(熊本県),鹿児島大学(鹿児島県)

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1093/jjco/hyv056
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
2008 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 07 Month 01 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 19 Day
Last modified on
2015 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001912

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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