UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001793
Receipt No. R000002163
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) Additional study:Gastrointestinal transit time as an indicator
Date of disclosure of the study information 2009/03/24
Last modified on 2015/11/27

* 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 Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Additional study:Gastrointestinal transit time as an indicator
Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
Additional study:Gastrointestinal transit time as an indicator
(JFMC39-0902 Additional study)
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Additional study:Gastrointestinal transit time as an indicator
Scientific Title:Acronym Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
Additional study:Gastrointestinal transit time as an indicator
(JFMC39-0902 Additional study)
Region
Japan

Condition
Condition Colon cancer (Sigmoidal and Rectosigmoidal regions)
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 intestinal dysmotility following laparotomy for colon cancer by radiopaque marker to measure gastrointestinal transit time.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Total number of elimination of the markers
Key secondary outcomes 1) Time to first flatus (hr) after nasogastric tube removal
2) Segmental transit time (gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))

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 A capsule of radiopaque markers is taken with test drug(Daikenchuto) orally at 8:00 a.m. on postoperative day 2.
Interventions/Control_2 A capsule of radiopaque markers is taken with test drug(placebo) orally at 8:00 a.m. on postoperative day 2.
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)Participate in JFMC39-0902
2)Amenable to curative resection in colon cancer (Sigmoidal and Rectosigmoidal regions)
3)Patients who can provide written informed consent
Key exclusion criteria 1)Patients who are unfit for the study as determined by the attending physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koutarou Maeda
Organization Fujita Health University
Division name School of Medicine. Department of Gastro-enterological surgery
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi-Ken. 470-1192, Japan
TEL 0562-93-2111
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 岩手医科大学(岩手県),群馬大学(群馬県),亀田総合病院(千葉県),帝京大学ちば総合医療センター(千葉県),杏林大学(東京都),富山大学(富山県),藤田保健衛生大学(愛知県),四日市社会保険病院(三重県),関西医科大学附属枚方病院(大阪府),広島大学(広島県),香川県立中央病院(香川県),大分大学(大分県)

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007%2Fs00535-015-1100-1
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
2009 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study which was started by the DKT Forum Clinical Pharmacology team in March 2009 is taken over as the additional study in UMIN's unique trial number UMIN000001592.

Management information
Registered date
2009 Year 03 Month 24 Day
Last modified on
2015 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002163

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.