UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033830 |
|---|---|
| Receipt number | R000038586 |
| Scientific Title | Randomized control trial between OPB-2045G and PVI |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/06/04 11:36:09 |
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Basic information
Public title
Randomized control trial between OPB-2045G and PVI
Acronym
RCT between OPB and PVI
Scientific Title
Randomized control trial between OPB-2045G and PVI
Scientific Title:Acronym
RCT between OPB and PVI
Region
| Japan |
Condition
Condition
Patients undergoing operation with intestinal opening
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
OPB can reduce the rate of SSI.
Basic objectives2
Others
Basic objectives -Others
subgroup analysis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
the rate of SSI
Key secondary outcomes
Influent factors of SSI
analysis of bacteria inducing SSI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OPB-2045G
Interventions/Control_2
PVI
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing operation including intestinal opening and hepatectomy.
Key exclusion criteria
Patients disagreed.
Patients who may have allergy for this drug.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
020-0866
Address
5-15-1 Motomiya, Morioka
TEL
019-635-0101
aumemura@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
020-0866
Address
5-15-1 Motomiya, Morioka city
TEL
019-635-0101
Homepage URL
aumemura@iwate-med.ac.jp
Sponsor or person
Institute
Morioka Municipal Hospital
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Morioka Municipal Hospital
Department of Surgery
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
Department of Surgery, Morioka Municipal Hospital
Address
5-15-1 Motomiya Morioka
Tel
019-635-0101
aumemura@iwate-med.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
盛岡市立病院 外科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | 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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
under analyzing
Management information
Registered date
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038586
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
