KRP-AM1977X Phase III Comparative Study (sinusitis)
Phase 3
Completed
- Conditions
- Sinusitis (severity of infection: moderate to severe)
- Registration Number
- JPRN-jRCT2080222862
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
The non-inferiority of KRP-AM1977X versus LVFX was demonstrated in the clinical efficacy rate at the end-of-treatment.In the safety assessment, no major problem was observed in KRP-AM1977X.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 279
Inclusion Criteria
Sinusitis with clear infection symptoms
Exclusion Criteria
Sinusitis patient except Fungal Rhinosinusitis, eosinophilic sinusitis, etc.
Patient with serious functional disorder that would unsuitable for the study
Patient showing the tendency to improve sinusitis 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 the end of treatment
- Secondary Outcome Measures
Name Time Method efficacy<br>Recurrence rate at the test of cure, etc.