Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Registration Number
- NCT01510535
- Lead Sponsor
- LG Life Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and then LBSA0103 Placebo 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. Placebo and then LBSA0103 LBSA0103 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. Hyruan Plus Hyruan Plus The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.
- Primary Outcome Measures
Name Time Method Weight-bearing pain 12 weeks after the last injection using 100mm-VAS
- Secondary Outcome Measures
Name Time Method WOMAC-likert assessment 1,6,12 weeks after the last injection Pain, Function, Stiffness, Total score
Weight-bearing pain 1,6 weeks after the last injection using 100mm-VAS
Patient Global Assessment 1,6,12 weeks after the last injection using 100mm-VAS
Investigator Global Assessment 1,6,12 weeks after the last injection using 100mm-VAS
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Jongno-gu, Seoul, Korea, Republic of