UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012125
Receipt number 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 14:42:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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

Region

Japan


Condition

Condition

Atypical 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 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


Assessment

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



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 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

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 or person

Institute

Toyama Chemical Co., Ltd.

Institute

Department

Personal name



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)00190-1/pdf

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



Progress

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name