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

NCT01510535 | Completed Phase 3

• 1 other identifier: LG-HACL010
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoartritis; Knee; LBSA0103; Hyruan Plus Inj.

Outcome Measures

Primary Outcomes (1)

• Weight-bearing pain

  using 100mm-VAS

  12 weeks after the last injection

Secondary Outcomes (4)

• Weight-bearing pain

  1,6 weeks after the last injection

• WOMAC-likert assessment

  1,6,12 weeks after the last injection

• Patient Global Assessment

  1,6,12 weeks after the last injection

• Investigator Global Assessment

  1,6,12 weeks after the last injection

Study Arms (2)

Placebo and then LBSA0103

EXPERIMENTAL

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; Drug: LBSA0103

Hyruan Plus

ACTIVE COMPARATOR

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

Drug: Hyruan Plus

Interventions

Placebo DRUG

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

Placebo and then LBSA0103

Hyruan Plus DRUG

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

Hyruan Plus

LBSA0103 DRUG

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

Placebo and then LBSA0103

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28549436 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 16, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

KR (1)