UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003897 |
|---|---|
| Receipt number | R000004647 |
| Scientific Title | Evaluation of efficacy and safety of fluoroquinolone in patients with nongonococcal urethritis |
| Date of disclosure of the study information | 2010/07/31 |
| Last modified on | 2010/07/03 01:30:38 |
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Basic information
Public title
Evaluation of efficacy and safety of fluoroquinolone in patients with nongonococcal urethritis
Acronym
Evaluation of efficacy and safety of fluoroquinolone in patients with nongonococcal urethritis
Scientific Title
Evaluation of efficacy and safety of fluoroquinolone in patients with nongonococcal urethritis
Scientific Title:Acronym
Evaluation of efficacy and safety of fluoroquinolone in patients with nongonococcal urethritis
Region
| Japan |
Condition
Condition
nongonococcal urethritis (Chlamydia trachomatis urethritis, Mycoplasma genitalium urethritis)
Classification by specialty
| Infectious disease | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and safety of levofloxacin 500mg administered orally once daily in patients with nongonococcal urethritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bacteriological efficacy two weeks after the end of treatment by levoflixacin
Key secondary outcomes
clinical efficacy two weeks after the end of treatment by levofloxacin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levofloxacin 500mg once daily p.o. 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
| Not applicable |
Gender
Male
Key inclusion criteria
1)age: more than 20 years old
2)sex: male
3)outpatient or hospitalization: both are included
4)patient with suspicious symptoms of nongonococcal urethritis
5)patient detected C. trachomatis or M. genitalium by bacteriological examination
Key exclusion criteria
1)patient detected N.gonorrhoeae by microscopic examination or bacteriological examination etc.
2)patient who has been administered other antibiotics and his symptom has been improved before starting administration of the study drug
3)patient administered fluoroquinolone within a week before starting administration of the study drug
4)patient with severe infection desease, who cannot be expected efficacy of oral administration therapy
5)patient with severe underlying disease or complications, who cannot be evaluated efficacy and safety of the study drug
6)patient with a history of fluoroquinolone allergies
7)patient with severe cardiac or hepatic dysfunction
8)patient with moderate renal dysfunction (Criteria: Serum Creatinine >= 2mg/dL)
9)patient with convulsive disorders like epilepsy or with a history of these deseases
10)patient disqualified as target by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Onodera |
Organization
Jikei University School of Medicine
Division name
Department of Infectious Diseases and Infection Control
Zip code
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei University School of Medicine
Division name
Department of Infectious Diseases and Infection Control
Zip code
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Infectious Diseases and Infection Control, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Infectious Diseases and Infection Control, Jikei University School of Medicine
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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2010 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
