A Phase II Study of SI-613 in Patients with Knee Osteoarthritis
Phase 2
- Conditions
- Knee Osteoarthritis
- Registration Number
- JPRN-UMIN000010167
- Lead Sponsor
- SEIKAGAKU CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
-Patients with secondary OA resulting from trauma or other diseases -Patients with risk of infection in the area of the injection site due to skin disease or infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Outcome: Change from baseline of WOMAC 3.1 Index (Pain)
- Secondary Outcome Measures
Name Time Method Efficacy Outcome: WOMAC 3.1 Index Safety Outcome: Adverse events Clinical laboratory tests