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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo and then 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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

LBSA0103

Intervention Type DRUG

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

Hyruan Plus

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

Group Type ACTIVE_COMPARATOR

Hyruan Plus

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Hyruan Plus

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

Intervention Type DRUG

LBSA0103

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No