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

Phase 3

Completed

• Conditions: Osteoarthritis of Knee
• Interventions: Drug: Humia inj.; Drug: High hyal Plus inj.

• Registration Number: NCT02893098
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Primary Completion: 2017-10
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline of Weight-bearing pain (100mm-VAS)	Week 14

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Huons; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of