UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006055 |
|---|---|
| Receipt number | 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 22:49:48 |
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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
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
yiroshi@belle.shiga-med.ac.jp
Sponsor or person
Institute
SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007166
