UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003744 |
|---|---|
| Receipt number | 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 18:46:27 |
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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
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
Kiyoshi@morinaga.org
Sponsor or person
Institute
Society of Kansai UTI
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004497
