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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003852
Receipt No. R000004259
Scientific Title Clinical study on biliary infection therapy :A RCT on clinical efficacy of DRPM in biliary tract infection with IPM/CS as comparator
Date of disclosure of the study information 2010/07/01
Last modified on 2019/07/29

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Basic information
Public title Clinical study on biliary infection therapy :A RCT on clinical efficacy of DRPM in biliary tract infection with IPM/CS as comparator
Acronym Clinical study on biliary infection therapy
Scientific Title Clinical study on biliary infection therapy :A RCT on clinical efficacy of DRPM in biliary tract infection with IPM/CS as comparator
Scientific Title:Acronym Clinical study on biliary infection therapy
Region
Japan

Condition
Condition Acute biliaring infection
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of DRPM on biliary infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Clinical effectiveness
Key secondary outcomes Clinical effectiveness at 3,7days

Safety(moniterd clinical and laboratory evaluation)

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DRPM
Interventions/Control_2 IPM/CS
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 Acute biliary infection
Key exclusion criteria 1)History of hypersensitivity to DRPM
2)Serious complications
3)Serious cardiac disfunctions
4)Serious renal disfunctions
5)With CNS disorder
6)History of hypersensitivity to B-lactam antibiotics
7)Pregnant or lactating women and women who may be pregnant
8)MRSA infection
9)Judged by investigator not to be appropriate for inclusion in this study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Tazuma
Organization graduate school of biomedicalscience, Hiroshima university.
Division name Department of General Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Email stazuma@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Tazuma
Organization graduate school of biomedicalscience, Hiroshima university.
Division name Department of General Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Homepage URL
Email stazuma@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university hospital
Department of General Internal Medicine
Institute
Department

Funding Source
Organization Hiroshima university hospital
Department of General Internal Medicine
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
Email

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 広島大学大学院(広島県) 
東邦大学医療センター大森病院(東京都)
藤田保健衛生大学坂文種報徳會病院(愛知県)
名古屋市立大学大学院(愛知県)
千葉大学大学院医学究院(千葉県)
山口大学大学院(山口県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 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
2010 Year 03 Month 16 Day
Date of IRB
2010 Year 06 Month 01 Day
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 01 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004259

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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