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Retreatment with LBSA0103 in Knee Osteoarthritis
NCT02122601Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2014
- Primary completion
- May 2015
- Countries
- 1
- Sponsor
- LG Chem
- Modality
- Hydrogel Systems, Nanoparticles, Device-based Delivery
- Conditions
- osteoarthritis of the knee (OA)
01
Overview
Phase 3, open-label, single-arm trial of cross-linked sodium hyaluronate gel in osteoarthritis of the knee (OA), sponsored by LG Chem. Primary endpoint: Adverse events for 13 weeks after the first and second administration. Started Apr 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
LBSA0103
Patients receive LBSA0103 at Week 0 and Week 26
03
Who it enrols
Patients aged 40 or older with knee osteoarthritis (K&L Grade I-III) and weight-bearing pain >= 40mm. Excludes BMI > 32, severe inflammation, recent HA or steroid injections, and significant liver/kidney dysfunction.
04
Endpoints
Primary
Adverse events for 13 weeks after the first and second administration
Secondary
Local reactions at injection site after the first and second administration
Change of Weight-bearing pain (100mm-VAS) from baseline
Change of WOMAC-likert assessment: Pain, Function, stiffness, Total score from baseline
Change of Patient Global Assessment (100mm-VAS) from baseline
Change of Investigator Global Assessment (100mm-VAS) from baseline
Change of rest pain(100mm-VAS) from baseline
Change of night pain(100mm-VAS) from baseline
Change of motion pain(100mm-VAS) from baseline
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