KRP-AM1977X Phase II Clinical Study
Phase 2
Completed
- Conditions
- Mild to moderate community acquired pneumonia (including Mycoplasma pneumonia, Chlamydia Pneumonia, or Legionella pneumonia)
- Registration Number
- JPRN-jRCT2080222226
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
The cure rate at the test-of-cure was more than 90% each in the 75 mg/day group and the 150 mg/day group. The cure rate at the test-of-cure in the 150 mg/day group was higher than that in the 75 mg/day group. In the safety assessment, no major problem was observed in the 75 mg/day group, and a drug related serious adverse event was observed in the 150 mg/day group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 129
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Clinical efficacy at test of cure
- Secondary Outcome Measures
Name Time Method efficacy<br>Clinical efficacy at end of treatment