UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.
Title of the study (Brief title)	Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptom after distal gastrectomy in gastric cancer patients.
Region	Japan

Condition
Condition	Gastric cancer patients with gastrointestinal symptom (abdominal pain, distention) after distal gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose in this study is an investigation for clinical efficacy of daikenchuto (TJ-100) on abdominal pain and distention after distal gastrectomy in gastric cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) gastrointestinal symptom (abdominal pain/distention/number of bowel movements per day after operation)
Key secondary outcomes	1) QOL assessment by the GSRS questionnaire 2) The evaluation of gastrointestinal motility using the cine MRI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of daikenchuto(15.0g/day, t.i.d.) before meals from postoperative day 2 to postoperative day 9. (postoperative day 2 at before an evening meal start administration.)
Interventions/Control_2	Standard of care
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	In order to participate in this study, a patient must meet all of the following criteria. 1) Patietnt with Clinical Stage: IA-IIB before surgery 2) Patient who recieved open or laparoscopic gastrectomy 3) Patient with abdominal pain and distention 1day after surgery 4) Patient with reconstruction: Billroth I 5) Patient with PS (ECOG Performance Status Scale): 0,1 6) Age: 20 years or older, under 75 years 7) Gender: no specification 8) Inpatient/Outpatient: Inpatient 9) Patient who can provide written informed consent
Key exclusion criteria	In order to participate in this study, a patient must not meet any of the following criteria. 1) Patients scheduled to be under postoperative artificial respiration 2) Patients with concomitant or history of inflammatory bowel disease such as ulcerative colitis and Crohn's disease 3) Patients with double cancer 4) Patients with peritoneal metastasis 5) Patients with history of the intestine and colon resections 6) Patient having the dysfunction of the main organ (bone marrrow, heart, liver, kidney, lung and others) 7) Patients with history of laparotomy or peritonitis (excluding surgery for appendicitis) 8) Patients who are administered another Kampo medicines for treatment within 4 weeks before the test drug administration 9) Patients who is an impossible to have oral administration of the test drug 10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 11) Others, patients who are unfit for the study as determined by the attending physician
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Yamamoto
Organization	SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Division name	Gastroenterological Surgery
Address	Seta Tsukinowa-cho, Otsu, Shiga 520-2192
TEL	077-548-2238
Email	yhiroshi@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiroshi Yamamoto
Organization	SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Division name	Gastroenterological Surgery
Address	Seta Tsukinowa-cho, Otsu, Shiga 520-2192
TEL	077-548-2238
Homepage URL	http://www.shiga-med.ac.jp/e/department/ekouza/110.html
Email	yiroshi@belle.shiga-med.ac.jp

Sponsor
Institute	SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	滋賀医科大学附属病院(滋賀）/ SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL (Shiga)

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 27 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2013 Year 05 Month 31 Day
Date of closure to data entry	2013 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 27 Day
Last modified on	2017 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007166