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

Osteoarthritis of Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893098
• Other study ID #: HU-025 P3
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2016
• Last updated: April 10, 2018
• Start date: August 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

• Kellgren-Lawrence Grade ? to ? 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Humia inj.
Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
• High hyal Plus inj.
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Huons	Ansan-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Weight-bearing pain (100mm-VAS)		Week 14
Secondary	Change from baseline of Weight-bearing pain (100mm-VAS)		Weeks 3, 8, 14, and 26
Secondary	Change from Visit 8 of Weight-bearing pain (100mm-VAS)		Week 38
Secondary	Physical Examination : Swelling		Weeks 0, 3, 8, 14, 26, and 38
Secondary	Physical Examination : Tenderness on pressure		Weeks 0,3,8,14,26,and 38
Secondary	Physical Examination : Range of motion		Weeks 0, 3, 8, 14, 26, and 38
Secondary	Consumption of rescue medication		Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Secondary	Proportion (%) of patients taking rescue medication		Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Secondary	Responder Rate		Week 14