A Open-label Study of S-033188 Granules in Otherwise Healthy Pediatric Patients With Influenza
Phase 3
Completed
- Conditions
- Influenza A and/or B virus infection
- Registration Number
- JPRN-jRCT2080223755
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Single oral dose of S-033188 2% granules investigated in this study is considered to be well tolerated and effective in pediatric patients with influenza virus infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Patients confirmed with influenza virus infection and within 48 hours from onset.
- Patients whose body weight is less than 20 kg.
Exclusion Criteria
- Patients with severe symptoms of influenza virus infection requiring inpatient treatment.
- Patients with high risk factors.
- Patients with concurrent infections requiring antimicrobial therapy.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of patients with any adverse events, etc.
- Secondary Outcome Measures
Name Time Method efficacy<br>time to alleviation of influenza illness, etc.