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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
Hyruan Plus
LBSA0103
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Placebo and then LBSA0103

Hyruan Plus

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Weight-bearing pain
using 100mm-VAS

Secondary Outcome Measures

Weight-bearing pain
using 100mm-VAS
WOMAC-likert assessment
Pain, Function, Stiffness, Total score
Patient Global Assessment
using 100mm-VAS
Investigator Global Assessment
using 100mm-VAS

Full Information

First Posted
January 6, 2012
Last Updated
January 16, 2013
Sponsor
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01510535
Brief Title
Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo and then LBSA0103
Arm Type
Experimental
Arm Description
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.
Arm Title
Hyruan Plus
Arm Type
Active Comparator
Arm Description
The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
First 2 weeks Placebo(2ml) once weekly in experimental group
Intervention Type
Drug
Intervention Name(s)
Hyruan Plus
Intervention Description
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
Intervention Type
Drug
Intervention Name(s)
LBSA0103
Intervention Description
at third week LBSA0103(60mg) once in experimental group
Primary Outcome Measure Information:
Title
Weight-bearing pain
Description
using 100mm-VAS
Time Frame
12 weeks after the last injection
Secondary Outcome Measure Information:
Title
Weight-bearing pain
Description
using 100mm-VAS
Time Frame
1,6 weeks after the last injection
Title
WOMAC-likert assessment
Description
Pain, Function, Stiffness, Total score
Time Frame
1,6,12 weeks after the last injection
Title
Patient Global Assessment
Description
using 100mm-VAS
Time Frame
1,6,12 weeks after the last injection
Title
Investigator Global Assessment
Description
using 100mm-VAS
Time Frame
1,6,12 weeks after the last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Jongno-gu
State/Province
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28549436
Citation
Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.
Results Reference
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Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

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