UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	npo crec net
Institute
Department

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
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

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
URL(English)	https://upload.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
Registered date	File name

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