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

Huons

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of Knee

Treatments: Drug: High hyal Plus inj.; Drug: Humia inj.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02893098

HU-025 P3

Details and patient eligibility

About

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

Enrollment: 232 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

232 participants in 2 patient groups

Humia inj.

Experimental group

Description:

Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.

Treatment:

Drug: Humia inj.

High Hyal Plus inj.

Active Comparator group

Description:

Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks

Treatment:

Drug: High hyal Plus inj.