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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009852
Receipt No. R000011540
Scientific Title clinical efficacy of sitafloxacin( 200mg daily)against female patients with acute cystitis
Date of disclosure of the study information 2013/02/01
Last modified on 2014/07/30

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Basic information
Public title clinical efficacy of sitafloxacin(
200mg daily)against female patients with acute cystitis
Acronym clinical efficacy of sitafloxacin for acute cystitis
Scientific Title clinical efficacy of sitafloxacin(
200mg daily)against female patients with acute cystitis
Scientific Title:Acronym clinical efficacy of sitafloxacin for acute cystitis
Region
Japan

Condition
Condition Acute cystitis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to clarify the efficacy and safety of sitafloxacin against acute cystitis,clinical effect of sitafloxacin(200mg daily)for the female patients with acute cystitis is evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication of symptoms and causative organisms after administration of sitafloxacin.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sitafloxacin(200mg daily)
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 (1)age,sex:20 years old or older,female
(2)inclusion criteria
1)symptoms:miction pain ,urinary urgency, pollakisuria,lower abdominal pain,or sever of residual urine.
2)pyuria:white blood cells is 5/hpf or more in urinary sediment.
3)bacterial count:104 CFU/mL in catheterized urine or105 CFU/mL in midstream urine.
Key exclusion criteria (1)Patient who has urinary catheter.
(2)Patient who has urinary diversion.
(3)Patient who has been administered other antibiotics and her symptom has been improved before starting administration of this study.
(4)Patient administered sitafloxacin within a week before starting administration of this study.
(5)Patient with severe infectious disease, who cannot be expected efficacy of oral antimicrobials therapy.
(6)Patient with severe underlying disease or complications, who cannot be evaluated efficacy and safety of this study.
(7)Patient with a history of allergies against fluoroquinolone.
(8)Patient with severe cardiac or hepatic dysfunction.
(9)Patient with moderate renal dysfunction (Criteria: Serum Creatinine >2mg/dL)
(10)Patient with convulsive disorders like epilepsy or with a history of these deseases.
(11)Pregnant women.
(12)Patient disqualified as target by doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi kiyota
Organization Jikei university katsushika medical center
Division name Department of urology
Zip code
Address 6-41-2,aoto,katsushika-ku,tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jikei university katsushika medical center
Division name Department of urology
Zip code
Address 6-41-2,aoto,katsushika-ku,tokyo
TEL
Homepage URL
Email

Sponsor
Institute Jikei university katsushika medical center,Department of urology
Institute
Department

Funding Source
Organization Daiichi-sankyo.co
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The efficacy of STFX against the female patients with AUC due to E,coli was moderately low in this study.longer regimen of STFX might be necessary for AUC.
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
2011 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 12 Day
Date of closure to data entry
2013 Year 03 Month 12 Day
Date trial data considered complete
2013 Year 03 Month 12 Day
Date analysis concluded
2014 Year 03 Month 24 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 23 Day
Last modified on
2014 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011540

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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