A Phase III, comparative study of KRP-AM1977Y in community- acquired pneumonia
Phase 3
Completed
- Conditions
- Community acquired pneumonia (including Mycoplasma pneumonia, Chlamydia Pneumonia, or Legionella pneumonia)
- Registration Number
- JPRN-jRCT2080223246
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
The non-inferiority of KRP-AM1977Y versus LVFX was demonstrated in the cure rate at the test-of-cure. In the safety assessment, no clinically significant finding was reported in KRP-AM1977Y.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 286
Inclusion Criteria
Community acquired pneumonia with clear infection symptoms
Exclusion Criteria
Pneumonia patient except the community-acquired pneumonia
Patient with serious functional disorder that would unsuitable for the study
Patient showing the tendency to improve pneumonia symptoms by other agents
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Clinical efficacy at test of cure<br>Assessment of clinical response by comparing the clinical findings and chest X-ray or CT results.
- Secondary Outcome Measures
Name Time Method efficacy<br>Clinical efficacy at end of treatment, etc.<br>Assessment of clinical response by comparing the clinical findings and chest X-ray or CT results.