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 UMIN000005056
Receipt No. R000006011
Scientific Title Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Date of disclosure of the study information 2011/03/01
Last modified on 2012/05/29

* 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 effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Acronym Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Scientific Title Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Scientific Title:Acronym Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomy
Region
Japan

Condition
Condition Patients with pancreatic head tumors undergoing pancreaticoduodenectomy

Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for accompanying abdominal symptoms (abdominal bloating, etc.) in intestinal dysmotility following pancreaticoduodenectomy.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Number of postoperative day to comfirm normal bowel sound.
2)Number of postoperative day to comfirm first flatus.
3)Abdominal circumference
4)Bowel gas image

Key secondary outcomes 1)QOL assessment by the GSRS Score (Japanese Version)
2)Postoperative cytokine and diamine oxidase(DAO) level in serum and ascites
3)Incidence of postoperative intestinal obstruction
4)Incidence of postoperative complications
5)Postoperative length of stay

Base
Study type Interventional

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

Intervention
No. of arms 1
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 or after meals between preoperative day3 to postoperative day7
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 1)PS(ECOG Performance Status Scale):0-2
2)Patients who are diagnosed as abdominal pain or distention CTCAE&#8805;1 by the attending physician preoperatively (when they provide written informed consent)
3)Patients who is able to have oral intake of the test drugs
4)Age: 20 years or older
5)Gender: no specification
6)2weeks or more blank after therapy is needed in case of receiving chemoradiotherapy
7)Adequate organ function and operable patient
8)Patients who can provide written informed consent
Key exclusion criteria 1)Patients with ischemic heart disease requiring treatment
2)Patients with liver cirrhosis or active hepatitis
3)Patients with interstitial pneumonitis or emphysema
4)Patients with chronic renal failure requiring dialysis
5)Patients with active duplicative malignant disease affecting adverse event
6)Patients who are scheduled to undergo pancreaticoduodenectomy together with other organs
7)Patients with history of intestinal resection
8)Patients who are administered another gastrointestinal prokinetic agents
9)Patients who need another Kampo medicines for medical treatment
10)Others, patients who are unfit for the study as determined by the attending physician
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Kawai
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address
TEL
Homepage URL http://www.wakayama-med.ac.jp/med/2nd-surgery/index.html
Email

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Tsumura company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2011 Year 03 Month 01 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 Completed
Date of protocol fixation
2010 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 08 Day
Last modified on
2012 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.