UMIN-CTR Clinical Trial

Public title

Efficacy study of TJ-100 Tsumura daikenchuto extract granules, prescription drug, for the treatment of the postoperative ileus in patients undergoing hepatectomy.

Acronym

Efficacy study of TJ-100 Tsumura daikenchuto extract granules, prescription drug, for the treatment of the postoperative ileus in patients undergoing hepatectomy.

Scientific Title

Efficacy study of TJ-100 Tsumura daikenchuto extract granules, prescription drug, for the treatment of the postoperative ileus in patients undergoing hepatectomy.

Scientific Title:Acronym

Efficacy study of TJ-100 Tsumura daikenchuto extract granules, prescription drug, for the treatment of the postoperative ileus in patients undergoing hepatectomy.

Region

Japan

Condition

Postoperative ileus in subjects undergoing hepatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to explore whether TJ-100 Tsumura daikenchuto extract granules, prescription drug, is effective for abdominal distension and deterioration of QOL derived from post operative ileus in subjects undergoing hepatectomy. Additive purpose of the study is to explore biomarkers relating to efficacy and safety of the drug.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

* Patient assessment of abdominal distension [ Time Frame: Baseline and following 14 days of treatment ]
* Patient assessment of gastrointestinal symptoms rating scale [ Time Frame: Baseline and following 14 days of treatment ]

Key secondary outcomes

* Time to first flatus and time to first bowel movement after endotracheal intubation removal [ Time Frame: Baseline and following 12 days of treatment ]
* Blood ammonia level [ Time Frame: Baseline and following 12 days of treatment ]
* Blood CRP level [ Time Frame: Baseline and following 12 days of treatment ]
* Ascertain presence of bowel obstruction after surgery [ Time Frame: Baseline and following 14 days of treatment ]

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Test drug: TJ-100 daikenchuto
TJ-100 daikenchuto, 5g, extract granules. Tree times daily beginning on preoperative 3 days until postoperative 10 days of perioperative treatment.

Interventions/Control_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

In order to participate in this study, a patient must meet all of the following criteria:
1)Is scheduled hepatectomy
2)Is diagnosed with abdominal distention as pre-operative CTCAE grade is at least 2 ;
3)Is possible to take daikenchuto orally;
4)Has a pre-operative ECOG performance status of 0 to 2;
5)Is at least 20 years of age;
6)Is male or female;
7)Has confirmed that it has been for 4 weeks after receiving anticancer radiation or chemotherapy;
8)Is maintenance in function of bone marrow, hart, liver, kidney and lung;
9)Is hospitalized for surgery and recovery; and
10)Provides written informed consent prior to participation in the study.

Key exclusion criteria

In order to participate in this study, a patient must not meet any of the following criteria:
1)With a history of laparoscopic surgery
2)Requires emergency surgery
3)Has a history of taking kampo medicine within 4 weeks of taking test drug;
4)Has history of gastrectomy (synchrony and/or asynchrony) ;
5)Has history of colectomy (synchrony) ;
6)Has history of RFA;
7)Has been diagnosed with ulcerative colitis, Crohn's disease, or irritable bowel syndrome;
8)Requires chemotherapy or anticancer radiation in the perioperative period or within 4 weeks prior to surgery;
9)Requires chemotherapy, including TAE or anticancer radiation within postoperative 10 days;
10)Has serious condition of liver that might adversely affect their ability to participate in this study;
11)Is a pregnant, possibly pregnant, considering pregnancy or lactating female; and
12)Is otherwise unacceptable for enrollment in the opinion of the investigator.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiro Hanazaki

Organization

Kochi Medical School

Division name

Department of Surgery

Zip code

Address

Kohasu-Okocho, Nankoku-City, Kochi 783-8505, Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kochi Medical School

Division name

Department of Surgery

Zip code

Address

TEL

Homepage URL

Email

Institute

Department of Surgery, Kochi Medical School

Institute

Department

Personal name

Organization

TSUMURA & CO.

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2009

Year

12

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2009

Year

10

Month

31

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

28

Day

Last modified on

2011

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003589