Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Life Sciences

Criteria

Inclusion Criteria:

• Over 40 years of age

• Kellgren & Lawrence grade I-III

• If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS

• Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study

Exclusion Criteria:

• Body mass index > 32

• Have rheumarthritis

• Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS

• Have Sudek's atrophy, Paget's disease, Spinal disc herniation

• Kellgren & Lawrence Grade IV