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Completed

NCT Number: NCT01510535

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

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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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Hyruan Plus

Drug

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

LBSA0103

Drug

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

Primary outcomes

  1. Weight-bearing pain

    Time frame: 12 weeks after the last injection

    using 100mm-VAS

Secondary outcomes

  1. Weight-bearing pain

    Time frame: 1,6 weeks after the last injection

    using 100mm-VAS

  2. WOMAC-likert assessment

    Time frame: 1,6,12 weeks after the last injection

    Pain, Function, Stiffness, Total score

  3. Patient Global Assessment

    Time frame: 1,6,12 weeks after the last injection

    using 100mm-VAS

  4. Investigator Global Assessment

    Time frame: 1,6,12 weeks after the last injection

    using 100mm-VAS

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2012
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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