Status:
COMPLETED
Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
Lead Sponsor:
LG Life Sciences
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT01510535
Start Date
December 1 2011
End Date
October 1 2012
Last Update
January 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Jongno-gu, Seoul, South Korea