UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004509
Receipt No. R000005387
Scientific Title Clinical trial of sitafloxacin against non-gonococcal urethritis
Date of disclosure of the study information 2010/11/05
Last modified on 2013/11/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial of sitafloxacin against non-gonococcal urethritis
Acronym Clinical trial of STFX against NGU
Scientific Title Clinical trial of sitafloxacin against non-gonococcal urethritis
Scientific Title:Acronym Clinical trial of STFX against NGU
Region
Japan

Condition
Condition Non-gonococcal urethritis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The efficacy of STFX 200mg/day for 7days is examined against non-gonococcal
urethritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Microbiological efficacy of STFX against causative bacteria(mMycoplasma genitalium,Chlamydaia trachomatis,Ureaplasma urealyticum)is investigated in non-gonococcal urethritis.
Key secondary outcomes Clinical efficacy of STFX is investigated in non-gonococcal urethritis.
Validation of new nucleic acid amplification testing for detecting M.genitalium or U.urealyticum is validated.
Antimicrobial susceptibility of M.genitalium or U.urealyticum
Analysis of genome ralated to resistance to antimicrobials in M.genitalium

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 STFX 200mg/day 7days
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
65 years-old >=
Gender Male
Key inclusion criteria Outpatients with non-gonococcal urethritis between 20 and 65 years old.
Patients who undersutand the study and agree with written informed consent.
Ptients agree that they do not have sexual intercourse without using condom during the period of clinical trial.
Key exclusion criteria Patients who have allegy to fluoroquinolones
Patients with severe renal dysfunction
Patients who have a history of epilepsy.
Patients who have severe heart diseases including inchemic heart diseases or arrthythmia.
Target sample size 500

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoshi Takahashi
Organization Sapporo Medical university School of Medicine
Division name Department of Urology
Zip code
Address W.16 Chuo-ku, Sapporo, 060-8542,japan
TEL (011)611-2111
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Satoshi Takahashi
Organization Sapporo Medical university School of Medicine
Division name Department of Urology
Zip code
Address W.16 Chuo-ku, Sapporo, 060-8542,japan
TEL (011)611-2111
Homepage URL
Email

Sponsor
Institute NPO CREC net
Institute
Department

Funding Source
Organization Daiichisankyo
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 札幌医科大学附属病院泌尿器科(北海道)
ていね泌尿器科(北海道)
にっしん泌尿器科(北海道)
岐阜大学医学部附属病院(岐阜)
あいクリニック(宮城)
竹内クリニック(岐阜)
ふくだ泌尿器科(宮崎)
医療法人泌尿器科いとうクリニック(福岡)
医療法人かわい泌尿器科クリニック(福岡)
医療法人西村泌尿器科(福岡)
医療法人山口皮フ・泌尿器科(福岡)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 05 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 09 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 05 Day
Last modified on
2013 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.