KRP-AM1977X Phase III Open-label Study (Respiratory Tract Infection)

Phase 3

Completed

• Conditions: Secondary infection of chronic respiratory disease and acute bronchitis

• Registration Number: JPRN-jRCT2080222861
• Lead Sponsor: Kyorin Pharmaceutical Co.,LTD

Brief Summary

KRP-AM1977X was highly effective for both secondary infection of chronic respiratory disease and acute bronchitis. In the safety assessment, no major problem was observed in KRP-AM1977X.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-25
• Study Completion: 2016-12-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Respiratory tract infection with clear infection symptoms

Exclusion Criteria

Patient with severe infection
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>Secondary infection of chronic respiratory disease: Clinical efficacy at test of cure<br>Acute bronchitis: Clinical efficacy at end of treatment<br><br>Assessment of clinical response by comparing the clinical findings.

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Secondary infection of chronic respiratory disease: Clinical efficacy at end of treatment, etc.<br>Acute bronchitis: Clinical efficacy at test of cure, etc.<br><br>Assessment of clinical response by comparing the clinical findings.