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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510535
• Other study ID #: LG-HACL010
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2012
• Last updated: January 16, 2013
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Placebo
First 2 weeks Placebo(2ml) once weekly in experimental group
• Hyruan Plus
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
• LBSA0103
at third week LBSA0103(60mg) once in experimental group

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Jongno-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-bearing pain	using 100mm-VAS	12 weeks after the last injection	No
Secondary	Weight-bearing pain	using 100mm-VAS	1,6 weeks after the last injection	No
Secondary	WOMAC-likert assessment	Pain, Function, Stiffness, Total score	1,6,12 weeks after the last injection	No
Secondary	Patient Global Assessment	using 100mm-VAS	1,6,12 weeks after the last injection	No
Secondary	Investigator Global Assessment	using 100mm-VAS	1,6,12 weeks after the last injection	No