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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510535

Enrollment

287

Registered

2012-01-16

Start date

2011-12-31

Completion date

2012-10-31

Last updated

2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.

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.

Interventions

DRUGPlacebo

First 2 weeks Placebo(2ml) once weekly in experimental group

DRUGHyruan Plus

Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group

DRUGLBSA0103

at third week LBSA0103(60mg) once in experimental group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Weight-bearing pain	12 weeks after the last injection	using 100mm-VAS

Secondary

Measure	Time frame	Description
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026