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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002952
Receipt No. R000003589
Scientific Title Efficacy study of TJ-100 Tsumura daikenchuto extract granules, prescription drug, for the treatment of the postoperative ileus in patients undergoing hepatectomy.
Date of disclosure of the study information 2009/12/28
Last modified on 2011/09/29

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Basic information
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
Condition Postoperative ileus in subjects undergoing hepatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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 ]

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Surgery, Kochi Medical School
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2009 Year 12 Month 28 Day
Last modified on
2011 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003589

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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