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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003744
Receipt No. R000004497
Scientific Title Clinical research for acute uncomplicated cystitis
Date of disclosure of the study information 2010/06/30
Last modified on 2012/12/13

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Basic information
Public title Clinical research for acute uncomplicated cystitis
Acronym Clinical research for acute uncomplicated cystitis
Scientific Title Clinical research for acute uncomplicated cystitis
Scientific Title:Acronym Clinical research for acute uncomplicated cystitis
Region
Japan

Condition
Condition acute uncomplicated cystitis
Classification by specialty
Infectious disease Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Against acute uncomplicated cystitis,the suitable medication periord of new oral cephem type agent is examined based on new guideline for clinical research of antimicrobial agents on urogenital infections.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The bacteriology effect in the 5th day -9th day after the medication.
Key secondary outcomes The clinical effect in the 5th day - 9th day after the medication.

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 cefcapen pivoxil
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 Female
Key inclusion criteria The patients who adapt to the condition of the new guideline for clinical research of antimicrobial agents on urogenital infections.
Key exclusion criteria The patients who do not adapt to the condition of the new guideline for clinical research of antimicrobial agents on urogenital infections.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadao Kamidono
Organization Society of Kansai UTI
Division name Representative
Zip code
Address 1-3-1,Wakinohamakaigandori,Chuo-Ku Kobe,651-0073,Japan
TEL 078-231-6026
Email

Public contact
Name of contact person
1st name
Middle name
Last name kiyoshi morinaga
Organization Society of Kansai UTI
Division name Bureau
Zip code
Address 520-1823 614 Nasyou-makino takasima-ci Siga Japan
TEL 0740-27-0904
Homepage URL
Email Kiyoshi@morinaga.org

Sponsor
Institute Society of Kansai UTI
Institute
Department

Funding Source
Organization THE KIDONEY FOUNDATION,JAPAN
Organization
Division
Category of Funding Organization Non profit foundation
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 神戸赤十字病院、まつもと泌尿器科、淀川キリスト教病院、新日鐵広畑病院、神戸百年記念病院、岡クリニック、三田市民病院、原泌尿器科病院

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 30 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
2009 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 10 Month 01 Day

Other
Other related information prospective studey,
random study

Management information
Registered date
2010 Year 06 Month 12 Day
Last modified on
2012 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004497

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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