UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032697 |
|---|---|
| Receipt number | R000037165 |
| Scientific Title | Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer |
| Date of disclosure of the study information | 2018/05/24 |
| Last modified on | 2019/05/26 13:33:25 |
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Basic information
Public title
Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Acronym
Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title
Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title:Acronym
Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether perioperative administration of TJ-100 affects postoperative recovery of gastrointestinal function in patients undergoing surgery for colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time until first flatus following colon surgery
Key secondary outcomes
1.The time until first defecation following colon surgery
2.CRP, WBC, neutrophil of POD 1,3
3.The maximumu of body temperature
4.Hospital stay after colorectal surgery
5.Postoperative complication
6.Adverse events
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
oral administration of TJ-100(15g/day) in perioperative surgery
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.Patients with curative resection for colon cancer including cancer of the rectosigmoid that had been diagnosed pre-operatively
2.Patients with a performance status of 0 or 1
3.Patients able to tolerate oral administration of TJ-100
4.Patients aged 20 years or older
5.Patients able to provide written informed consent
Key exclusion criteria
1.Patients taking other Kampo medicines
2.Patients were pregnant, possibly pregnant or considering pregnancy
3.Patients with serious ischemic heart disease
4.Patients with cirrhosis or active hepatitis
5.Patients with dyspnea requiring oxygen administration
6.Patients under dialysis due to chronic renal failure
7.Patients requiring combined resection of any other organ
8.Patients ineligible for the study for any other reason, as judged by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Nishidate |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
Homepage URL
nisidate@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
Sapporo, Hokkaido 060-8543, Japan
Tel
011-611-2111
rskk@sapmed.ac.jp
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
| 2018 | Year | 05 | Month | 24 | 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
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037165
