A Phase III Study of SI-613 in Patients with Knee Osteoarthritis (confirmatory study)
- Conditions
- Knee osteoarthritis
- Registration Number
- JPRN-jRCT2080223482
- Lead Sponsor
- SEIKAGAKU CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 440
Diagnosis of osteoarthritis of the knee according to American College of Rheumatology criteria at the time of screening.
Kellgren-Lawrence score grade 2 or 3 in an Antero-posterior weight-bearing x-ray of the target knee joint in the standing position taken at the time of screening.
Subjects who are willing to discontinue pain medication except as permitted per protocol from the start date of screening to the end of Week 24 after the first injection (using acetaminophen as a rescue medication is permitted for breakthrough pain control).
Secondary OA resulting from trauma or the other diseases in the target knee
Subjects who have pain in lower extremity other than knee OA if it would interfere with the evaluation of the target knee or have OA of the hip or ankle at screening and Week 0 before injection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>WOMAC 3.1 Index (Pain)<br>Change from baseline in WOMAC 3.1 Index (Pain) during 12 weeks
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>WOMAC total score<br>50-foot walk test<br>The incidence of adverse events