UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014656 |
|---|---|
| Receipt number | R000017051 |
| Scientific Title | The Usefulness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2016/12/08 15:56:34 |
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Basic information
Public title
The Usefulness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease
Acronym
The Usefulness of Doripenem as a postoperative therapeutic antibiotics
Scientific Title
The Usefulness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease
Scientific Title:Acronym
The Usefulness of Doripenem as a postoperative therapeutic antibiotics
Region
| Japan |
Condition
Condition
Resected cases with pancreato-biliary disease
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefuleness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the usefulness or non-inferiority of Doripenem to non-Carbapenem antibiotics in resected cases with pancreato-biliary disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To use Doripenemu for resected cases with pancreato-biliary disease
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Resected cases with pancreato-biliary disease
Key exclusion criteria
The cases which the doctors in charge judge inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura Kanazawa Yokohama Kanagawa
TEL
045-787-2650
ryutaromori@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura Kanazawa Yokohama Kanagawa
TEL
045-787-2650
Homepage URL
ryutaromori@gmail.com
Sponsor or person
Institute
Yokohama City University, Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University, Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 26 | Day |
Last modified on
| 2016 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017051
