UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009852 |
|---|---|
| Receipt number | 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 17:05:45 |
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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
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
Sponsor or person
Institute
Jikei university katsushika medical center,Department of urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
