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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012124
Receipt No. R000014155
Scientific Title Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial 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 bacterial pneumonia
Acronym Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against bacterial pneumonia
Scientific Title Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against bacterial pneumonia
Scientific Title:Acronym Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against bacterial pneumonia
Region
Japan

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

Objectives
Narrative objectives1 To confirm the efficacy and safety of Geninax(R) Tablets against bacterial 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., Streptococcus species, Escherichia coli, Klebsiella species, Enterobacter species, and Legionella pneumophila)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

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

Bacteriological efficacy

Adverse drug reaction during the observation period
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 Geninax(R) Tablets 200 mg was administered under the approved regimen (2 tablets of Geninax(R), once daily). The administration period was not limited.
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
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 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 purulent sputum or from whom a bacterial pathogen was presumed to be present in clinical specimens (e.g., sputum or urine)

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

Patients who could ingest orally

Patients who had no concomitant atypical pneumonia as confirmed by rapid diagnosis when Geninax(R) Tablets therapy was initiated

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 deems to be ineligible as a target
Target sample size 500

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
Email s-kohno@nagasaki-u.ac.jp

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
Email satoru_kushimoto@toyama-chemical.co.jp

Sponsor
Institute Toyama Chemical Co., Ltd.
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jiac-j.com/article/S1341-321X(14)00191-3/pdf
Number of participants that the trial has enrolled
Results
The safety in 730 patients and the efficacy in 535 patients were examined.
The efficacy rate of garenoxacin for bacterial pneumonia was 92.8% (479/516 patients). The eradication rates for Streptococcus pneumoniae and Haemophilus influenzae, the major pathogens of bacterial pneumonia, were 98.5% (65/66 strains) and 100% (65/65 strains), respectively.
The incidence of adverse drug reactions (including abnormal laboratory tests) was 7.9% (58/730 patients). Among the main adverse drug reactions, abnormal laboratory tests were observed in 2.1% patients (15/730), hepatobiliary disorders were observed in 1.8% patients (13/730), and skin and subcutaneous tissue disorders were observed in 1.6% patients (12/730).
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
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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