Trial record 1 of 1 for:    NCT01510535
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Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01510535
First received: January 6, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Placebo
Drug: Hyruan Plus
Drug: LBSA0103
Phase 3

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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Weight-bearing pain [ Time Frame: 12 weeks after the last injection ] [ Designated as safety issue: No ]
    using 100mm-VAS


Secondary Outcome Measures:
  • Weight-bearing pain [ Time Frame: 1,6 weeks after the last injection ] [ Designated as safety issue: No ]
    using 100mm-VAS

  • WOMAC-likert assessment [ Time Frame: 1,6,12 weeks after the last injection ] [ Designated as safety issue: No ]
    Pain, Function, Stiffness, Total score

  • Patient Global Assessment [ Time Frame: 1,6,12 weeks after the last injection ] [ Designated as safety issue: No ]
    using 100mm-VAS

  • Investigator Global Assessment [ Time Frame: 1,6,12 weeks after the last injection ] [ Designated as safety issue: No ]
    using 100mm-VAS


Enrollment: 287
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510535

Locations
Korea, Republic of
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01510535     History of Changes
Other Study ID Numbers: LG-HACL010
Study First Received: January 6, 2012
Last Updated: January 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by LG Life Sciences:
Osteoartritis
Knee
LBSA0103
Hyruan Plus Inj.

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014