Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia

Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia - Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012124

Enrollment

500

Registered

2013-10-25

Start date

2009-10-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial pneumonia

Interventions

Geninax(R) Tablets 200 mg was administered under the approved regimen (2 tablets of Geninax(R), once daily). The administration period was not limited.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Clinical efficacy at the termination of Geninax(R) Tablets therapy (assessed by primary physician) Bacteriological efficacy Adverse drug reaction during the observation period	—

Countries

Japan

Contacts

Public ContactSatoru Kushimoto

Toyama Chemical Co., Ltd. Post-Marketing Surveillance Group, Pharmacovigilance & Surveillance Department

satoru_kushimoto@toyama-chemical.co.jp03-5381-3877

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026