UMIN-CTR Clinical Trial

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

Colon cancer (Sigmoidal and Rectosigmoidal regions)

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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))

Study type

Interventional

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

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

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

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

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

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2009

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2009

Year

03

Month

24

Day

Last modified on

2015

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002163