ong Term Follow-up Study of SI-613 in Patients with OA
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- JPRN-jRCT2080223799
- Lead Sponsor
- SEIKAGAKU CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Subject who has diagnosed with OA by X-ray and observed a deformability change at the time of screening.
Subject who has OA pain in the target joint which is longer than or equal to 12 weeks prior to the time of informed consent.
Exclusion Criteria
Subjects who has significant joint deformation such as a large osteophyte or remarkable narrowing of the joint space.
Subject who is difficult to continue outpatient during informed concent and 52week.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The incidence of adverse events<br>Target joint examination<br>X-ray imaging test
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Target joint pain<br>WOMAC (knee and hip joints)<br>Shoulder 36 (shoulder joint)<br>PREE-J (elbow joint)<br>SAFE-Q (ankle joint)