UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004307 |
|---|---|
| Receipt number | R000005163 |
| Scientific Title | Clinical study of faropenem sodium to acute uncomplicated cystitis |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2013/06/11 21:12:09 |
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Basic information
Public title
Clinical study of faropenem sodium to acute uncomplicated cystitis
Acronym
Clinical study of faropenem sodium to acute uncomplicated cystitis
Scientific Title
Clinical study of faropenem sodium to acute uncomplicated cystitis
Scientific Title:Acronym
Clinical study of faropenem sodium to acute uncomplicated cystitis
Region
| Japan |
Condition
Condition
acute uncomplicated cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the optimal duration of administration with FRPM,microbiological
and clinical efficacy are examined in clinical study of FRPM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbiological efficacy on 5-9 days after the finishing the administration
of FRPM
Key secondary outcomes
Clinical efficacy of FRPM
Evaluation of recurrence after treatment
Safety of FRPM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FRPM 200mg twice a day (600mg/day)is administrated to patients for 3 days
Interventions/Control_2
FRPM 200mg twice a day (600mg/day)is administrated to patients for 7 days
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
Female outpatients over the age of 20,who are diagnosed with acute uncomplicated cystitis.
Patients who had any symptoms of pain on urination,frequent urination,urgency of urination or lower abdominal pain.
Patients who had pyuria with any categories below before the treatment;more than 10 WBC/mm3 in non-centrifuged urine specimen by testing equipment or calculated board, positive on non-centrifuged urine specimen by urine test strip or more than 5 WBC/mm3 in the urinary sediments.
Patients who had bacteriuria with more than 103 cfu/ml (Staphylococcus sp., Enterococcus faecalis, Streptococcus agalactiae or Enterobacteriaceae) before the treatment.
Key exclusion criteria
1.Patients infected with bacteria which can not expected efficacy of FRPM.
2.Patients with allergy to penicillins or chaparosporins.
3.Pregnant or lactating patients.
4.Patients with severe heart, liver or renal dysfunction.
5.Patients who had antimicrobial treatemt in 10 days
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Matsumoto |
Organization
University of Occupational and Environmental Health
Division name
Department of Urology
Zip code
Address
1-1,Iseigaoka,Yahata-nish-ku,kitakyushu,fukuoka,807-8555Japan
TEL
0936917446
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Occupational and Environmental Health
Division name
Department of Urology
Zip code
Address
1-1,Iseigaoka,Yahata-nish-ku,kitakyushu,fukuoka,807-8555Japan
TEL
0936917446
Homepage URL
Sponsor or person
Institute
npo crec net
Institute
Department
Personal name
Funding Source
Organization
npo crec net
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
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
細部医院（東京都）
げんき泌尿器科クリニック（東京都）
苫小牧王子総合病院（北海道）
国立病院機構函館病院泌尿器科（北海道）
川原腎・泌尿器科クリニック（鹿児島県）
まきのせ泌尿器科（鹿児島県）
下稲葉病院（鹿児島県）
肝属郡医師会立病院（鹿児島県）
医療法人山口皮フ・泌尿器科医院（福岡県）
医療法人かわい泌尿器科クリニック（福岡県）
医療法人泌尿器科いとうクリニック（福岡県）
医療法人山元泌尿器科医院（福岡県）
あいクリニック（宮城県）
泌尿器科皮膚科竹内クリニック（岐阜県）
しらね泌尿器科（広島県）
坂口泌尿器科クリニック（兵庫県）
たぐちクリニック（兵庫県）
やまもとクリニック泌尿器科（兵庫県）
鹿子木クリニック（兵庫県）
秋山泌尿器科（兵庫県）
いはらクリニック（兵庫県）
石川クリニック（兵庫県）
今井泌尿器科（兵庫県）
いまにし泌尿器科（兵庫県）
長久天満診療所（兵庫県）
まつむら泌尿器科（兵庫県）
しもがき泌尿器科クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | 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 | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 01 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
