ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
Not Applicable
Terminated
- Conditions
- Osteoarthritis
- Registration Number
- NCT00665574
- Lead Sponsor
- Carbylan Therapeutics, Inc.
- Brief Summary
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- Osteoarthritis (OA) grade 2 or 3.
- Symptoms in the treatment knee for at least 12 months.
- Fully ambulatory patient.
Exclusion Criteria
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in the WOMAC Pain subscale average score for the treatment knee. 26 weeks post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Daugavpils Pilsetas Centrala Slimnica
🇱🇻Daugavpils, Latvia
State Hospital of Traumatology and Orthopaedics
🇱🇻Riga, Latvia
Daugavpils Pilsetas Centrala Slimnica🇱🇻Daugavpils, Latvia