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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014994
Receipt No. R000017424
Official scientific title of the study Clinical study of Garenoxacin on male non-gonococcal urethritis
Date of disclosure of the study information 2014/08/30
Last modified on 2014/08/29

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Basic information
Official scientific title of the study Clinical study of Garenoxacin on male non-gonococcal urethritis
Title of the study (Brief title) Clinical study of Garenoxacin on male non-gonococcal urethritis
Region
Japan

Condition
Condition Non-gonococcal urethritis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of GRNX 400mg/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 GRNX against causative bacteria(mMycoplasma genitalium,Chlamydaia trachomatis,Ureaplasma urealyticum)is investigated in non-gonococcal urethritis.
Key secondary outcomes To evaluate the clinical efficacies of GRNX to non-gonococcal urethritis

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Garenoxacin 400mg 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Outpatients with non-gonococcal urethritis over 20 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 Patient with a history of allergies against fluoroquinolone.
Patient with convulsive disorders like epilepsy or with a history of these deseases.
Patients who have severe heart diseases including inchemic heart diseases or arrthythmia.
Patient with diabetis mellitus.
Patient with systolic blood pressure of patients below 90mmHg.
Patient with myasthenia gravis.

Target sample size 50

Research contact person
Name of lead principal investigator Hiroshi kiyota
Organization Jikei university katsushika medical center
Division name Department of urology
Address 6-41-2,aoto,katsushika-ku,tokyo
TEL 0336032111
Email kiyota@jikei.ac.jp

Public contact
Name of contact person Hiroshi kiyota
Organization Jikei university katsushika medical center
Division name Department of urology
Address 6-41-2,aoto,katsushika-ku,tokyo
TEL 0336032111
Homepage URL
Email kiyota@jikei.ac.jp

Sponsor
Institute Jikei university katsushika medical center,Department of urology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Jikei university katsushika medical center,Department of urology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 08 Month 30 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 14 Day
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 08 Month 29 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017424


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