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Recruitment status Completed
Unique ID issued by UMIN UMIN000012125
Receipt No. R000014149
Scientific Title Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against atypical pneumonia
Date of disclosure of the study information 2013/10/25
Last modified on 2018/09/25

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Basic information
Public title Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia
Acronym Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia
Scientific Title Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia
Scientific Title:Acronym Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia

Condition Atypical pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Narrative objectives1 To confirm the efficacy and safety of Geninax(R) Tablets against atypical pneumonia in daily clinical practice

To collect clinical data of patients with pneumonia caused by the following bacteria with which a sufficient number of patients infected could not be enrolled in the clinical studies of Geninax(R) Tablets (i.e., Mycoplasma pneumoniae and Chlamydophila pneumoniae)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Primary outcomes Clinical efficacy at the termination of Geninax(R) Tablets therapy (assessed by primary physician)

Adverse drug reaction during the observation period
Key secondary outcomes

Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Dynamic allocation
Institution consideration

No. of arms 1
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Geninax(R) Tablets 200 mg was administered under the approved regimen (2 tablets of Geninax(R), once daily). The administration period was not limited.

Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were 15 years or older

Patients who had a negative result on Streptococcus pneumoniae urinary antigen test

Patients who were differentiated as having suspected atypical pneumonia according to the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults

Patients who had infiltrative shadows that deemed to have appeared acutely and newly on chest radiographic images and not exceeded 2/3 of one lung

Patients who had respiratory symptoms (e.g., cough, chest pain, or dyspnea)

Patients who could ingest orally

Patients who did not require a combination of other antibiotics or steroids when Geninax(R) Tablets therapy was initiated

Patients who took no other antibiotics within 7 days before initiation of Geninax(R) Tablets therapy
Key exclusion criteria Patients who had a history of hypersensitivity to Geninax(R) Tablets or other quinolones

Patients who were pregnant or possibly pregnant or were lactating

Patients who were previously enrolled in the study

Patients in whom drug efficacy of Geninax(R) Tablets was difficult to assess

Other patients whom the primary physician deemed to be ineligible as a target
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki 852-8501, Japan
TEL 095-819-7273

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Kushimoto
Organization Toyama Chemical Co., Ltd.
Division name Post-Marketing Surveillance Group, Pharmacovigilance & Surveillance Department
Zip code
Address 2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo 160-0023, Japan
TEL 03-5381-3877
Homepage URL

Institute Toyama Chemical Co., Ltd.

Funding Source
Organization Toyama Chemical Co., Ltd.
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

URL related to results and publications
Number of participants that the trial has enrolled
Results The safety in 105 patients and the efficacy in 71 patients were examined.
1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients). The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain).
2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous
system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively.
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

Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information We did an interim presentation of this study at the 59th annual meeting of the Eastern Branch, Japanese Society of Chemotherapy.

Management information
Registered date
2013 Year 10 Month 25 Day
Last modified on
2018 Year 09 Month 25 Day

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Research Plan
Registered date File name

Research case data specifications
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Research case data
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