Back to resultsA Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Humia inj.
High hyal Plus inj.
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
Eligibility 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
Sites / Locations
- Huons
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Humia inj.
High Hyal Plus inj.
Arm Description
Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks
Outcomes
Primary Outcome Measures
Change from baseline of Weight-bearing pain (100mm-VAS)
Secondary Outcome Measures
Change from baseline of Weight-bearing pain (100mm-VAS)
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Physical Examination : Swelling
Physical Examination : Tenderness on pressure
Physical Examination : Range of motion
Consumption of rescue medication
Proportion (%) of patients taking rescue medication
Responder Rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02893098
Brief Title
A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Humia inj.
Arm Type
Experimental
Arm Description
Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
Arm Title
High Hyal Plus inj.
Arm Type
Active Comparator
Arm Description
Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Humia inj.
Intervention Description
Single injection of 3mL Humia inj.
Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
Intervention Type
Drug
Intervention Name(s)
High hyal Plus inj.
Intervention Description
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
Primary Outcome Measure Information:
Title
Change from baseline of Weight-bearing pain (100mm-VAS)
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change from baseline of Weight-bearing pain (100mm-VAS)
Time Frame
Weeks 3, 8, 14, and 26
Title
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Time Frame
Week 38
Title
Physical Examination : Swelling
Time Frame
Weeks 0, 3, 8, 14, 26, and 38
Title
Physical Examination : Tenderness on pressure
Time Frame
Weeks 0,3,8,14,26,and 38
Title
Physical Examination : Range of motion
Time Frame
Weeks 0, 3, 8, 14, 26, and 38
Title
Consumption of rescue medication
Time Frame
Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Title
Proportion (%) of patients taking rescue medication
Time Frame
Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Title
Responder Rate
Time Frame
Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Huons
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15588
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
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