UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033830
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email aumemura@iwate-med.ac.jp

Sponsor
Institute Morioka Municipal Hospital
Department of Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.