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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006055
Receipt No. R000007166
Scientific Title Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.
Date of disclosure of the study information 2011/08/01
Last modified on 2017/08/02

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Basic information
Public title Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.
Acronym Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptom after distal gastrectomy in gastric cancer patients.
Scientific Title Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Yamamoto
Organization SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Division name Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Hiroshi Yamamoto
Organization SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Division name Gastroenterological Surgery
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

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 12 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007166

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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