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

January 16, 2013 updated by: LG Life Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Jongno-gu, Seoul, Korea, Republic of
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Placebo
First 2 weeks Placebo(2ml) once weekly in experimental group
Drug: LBSA0103
at third week LBSA0103(60mg) once in experimental group
Active Comparator: Hyruan Plus
The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.
Drug: Hyruan Plus
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-bearing pain
Time Frame: 1,6 weeks after the last injection
using 100mm-VAS
1,6 weeks after the last injection
WOMAC-likert assessment
Time Frame: 1,6,12 weeks after the last injection
Pain, Function, Stiffness, Total score
1,6,12 weeks after the last injection
Patient Global Assessment
Time Frame: 1,6,12 weeks after the last injection
using 100mm-VAS
1,6,12 weeks after the last injection
Investigator Global Assessment
Time Frame: 1,6,12 weeks after the last injection
using 100mm-VAS
1,6,12 weeks after the last injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-HACL010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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