A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huons Co., Ltd.; Huons Co.,Ltd.

Criteria

Inclusion Criteria:

• Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain

• Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months

• Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm

• Able to walk without assistive devices

• Patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion criteria:

• Body Mass Index (BMI) > 32

• History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity

• Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months

• Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test

• Undergo Knee Replacement Surgery of the target knee