UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004509 |
|---|---|
| Receipt number | 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 10:00:14 |
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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
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
Public contact
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
Sponsor or person
Institute
NPO CREC net
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005387
