UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the clinical efficacy and number of days of administration of cefditoren pivoxil in the treatment of adult acute uncomplicated cystitis
Title of the study (Brief title)	Clinical efficacy of cefditoren pivoxil for adult cystitis
Region	Japan

Condition
Condition	Adult acute uncomplicated cystitis
Classification by specialty	Medicine in general Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify, in accordance with the UTI Guideline, the clinical usefulness of administering cefditoren pivoxil (Meiact MS(R) Tablets 100 mg) for 3 days and 7 days as a treatment for adult acute uncomplicated cystitis thought to be caused by general bacteria.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	- Bacteriological efficacy at 5~9 days after the completion of treatment. - Adverse events during the evaluation period (If causality cannot be denied: adverse drug reaction).
Key secondary outcomes	- Clinical efficacy at 5~9 days after the completion of treatment. - Judgment of recurrence at 4~6 weeks after the completion of treatment.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Cefditoren pivoxil (trade name: Meiact MS Tablets 100 mg) will be orally administered at 1 tablet, 3 times per day, for 3 days.
Interventions/Control_2	Cefditoren pivoxil will be orally administered at 1 tablet, 3 times per day, 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	1) Symptoms A body temperature of <37.5 degree Centigrade, with any of the following subjective symptoms: micturition pain, frequent urination, urinary urgency or lower abdominal pain. 2) Pyuria Presence of pyuria prior to the start of treatment, meeting any of the following criteria: - Using primitive urine, >=10 WBC/microL by flow cytometry or >=10 WBC/mm3 when using a counting chamber - Using primitive urine, a positive test for esterase: - Microscopic examination of urine sediment: >=5 WBC/hpf
Key exclusion criteria	1) Co-presence of another urinary tract infection in addition to acute uncomplicated cystitis. 2) Symptoms of urinary tract infection within 4 weeks prior to onset of the present infection. 3) Existence of systemic (diabetes mellitus, ongoing administration of an immunosuppressive agent, ongoing long-term administration of steroid, etc.) or local factors that might induce and/or promote a urinary tract infection. 4) Symptoms/findings have improved as a result of administration of another antimicrobial agent. 5) History of allergy, possibly due to cephem antibiotics. 6) A physical constitution that predisposes to development of bronchial asthma, rash, urticaria or other allergic symptoms. 7) Moderate or more severe renal dysfunction. 8) Women who are or may be pregnant, are breast-feeding, or desire to become pregnant during the study drug administration period. 9) Any other reason that the chief investigator judges as rendering a patient inappropriate for enrollment.
Target sample size	120

Research contact person
Name of lead principal investigator	Koichiro Wada
Organization	Okayama University Hospital
Division name	Department of Urology
Address	2-5-1 Shikata-cho, Okayama city
TEL
Email

Public contact
Name of contact person	Koichiro Wada
Organization	Okayama University Hospital
Division name	Department of Urology
Address
TEL
Homepage URL
Email	gmd17055@s.okadai.jp

Sponsor
Institute	Okayama Urological Research Group
Institute
Department

Funding Source
Organization	Okayama Urological Research Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 22 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 09 Day
Last modified on	2017 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012217