UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004542 |
|---|---|
| Receipt number | R000005428 |
| Scientific Title | Clinical study of gatiflixacin on male non-gonococcal urethritis |
| Date of disclosure of the study information | 2010/11/11 |
| Last modified on | 2010/11/11 13:28:33 |
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Basic information
Public title
Clinical study of gatiflixacin on male non-gonococcal urethritis
Acronym
GONG study
Scientific Title
Clinical study of gatiflixacin on male non-gonococcal urethritis
Scientific Title:Acronym
GONG study
Region
| Japan |
Condition
Condition
Non-gonococcal urethritis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the microbiological or clinical efficacies of garifloxacin against male non-gonococcal urethritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate the microbiological efficacies of gatifloxacin against microorganisms of non-gonococcal urethritis
To examine the antimicrobial susceptibilitities of Mycoplasma genitalium to fluoroquinolones
Key secondary outcomes
To evaluate the clinical efficacies of gatifloxacin to non-gonococcal urethritis
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
Gatifloxacin with 200mg is administrated twice a day for 7 days
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
Male patient with non-gonococcal urethritis
Key exclusion criteria
Patients with gonococcal urethritis Patients who have sexual intercourse without using condom
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Hamasuna |
Organization
University of Occupational and Environmental Health
Division name
Department of Urology
Zip code
Address
1-1,Iseigaoka,Yahata-nishi-ku,kitakyushu,fukuoka,807-8555,Japan
TEL
093-691-7446
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Hamasuna |
Organization
University of Occupational and Environmental Health
Division name
Department of Urology
Zip code
Address
1-1,Iseigaoka,Yahata-nishi-ku,kitakyushu,fukuoka,807-8555 Japan
TEL
093-691-7446
Homepage URL
hamaryo@med.uoeh-u.ac.jp
Sponsor or person
Institute
NPO CREC net
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 11 | Day |
Last modified on
| 2010 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005428
