NCT01510535

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

An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Placebo	First 2 weeks Placebo(2ml) once weekly in experimental group
DRUG	Hyruan Plus	Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
DRUG	LBSA0103	at third week LBSA0103(60mg) once in experimental group

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-03-01
• Completion: 2012-10-01
• First posted: 2012-01-16
• Last updated: 2013-01-17

Locations

1 site across 1 country: South Korea