UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060176 |
|---|---|
| Receipt number | R000068822 |
| Scientific Title | A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/23 11:26:49 |
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Basic information
Public title
A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Acronym
A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Scientific Title
A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Scientific Title:Acronym
A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Region
| Japan |
Condition
Condition
Non-gonococcal Urethritis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and Safety 21 to 28 Days After Initiation of Minocycline Treatment
Key secondary outcomes
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
Patients with non-gonococcal urethritis should receive minocycline 100 mg orally twice daily for 7 days. If testing at the start of minocycline therapy is positive for M. genitalium, sitafloxacin 100 mg should be added orally twice daily for an additional 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Symptoms: Patients presenting with symptoms of non-gonococcal urethritis.
Pyuria: Cases meeting any of the following criteria for pyuria prior to initiation of medication.
Using non-centrifuged urine with a designated device: >=10 WBCs/uL
Using non-centrifuged urine with a urine test strip method (based on esterase activity measurement): Positive
Urinalysis sediment microscopy: >=5 WBCs/hpf
Key exclusion criteria
1) Patients who received other antimicrobial agents prior to study drug initiation and whose symptoms were already improving
2) Patients who received tetracycline-class antimicrobial agents within one week prior to study drug initiation
3) Patients with severe underlying diseases or complications that would make it difficult to evaluate the efficacy and safety of the study drug
4) Patients with a history of allergy to tetracycline-class antimicrobial agents
5) Patients with severe cardiac dysfunction or hepatic dysfunction
6) Patients with moderate or greater renal impairment (serum creatinine >= 2 mg/dL as a guideline)
7) Other patients deemed unsuitable by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo,060-8543,JAPAN
TEL
+81-11-611-2111
yasuda7jpe@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo,060-8543,JAPAN
TEL
+81-11-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Hospital Institutional Review Board
Address
S1 W16,Chuo-ku,Sapporo,060-8543,JAPAN
Tel
+81-11-611-2111
ji-rskk@ml.sapmed.ac.jp
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
| 2025 | Year | 12 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068822
