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

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: LBSA0103; Drug: Placebo; Drug: Hyruan Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510535

LG-HACL010

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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287 participants in 2 patient groups

Placebo and then LBSA0103

Experimental group

Description:

The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee.

Treatment:

Drug: Placebo

Drug: LBSA0103

Hyruan Plus

Active Comparator group

Description:

The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.

Treatment:

Drug: Hyruan Plus