A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
1 other identifier
interventional
232
1 country
1
Brief Summary
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 12, 2018
April 1, 2018
1.2 years
August 17, 2016
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of Weight-bearing pain (100mm-VAS)
Week 14
Secondary Outcomes (8)
Change from baseline of Weight-bearing pain (100mm-VAS)
Weeks 3, 8, 14, and 26
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Week 38
Physical Examination : Swelling
Weeks 0, 3, 8, 14, 26, and 38
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
- +3 more secondary outcomes
Study Arms (2)
Humia inj.
EXPERIMENTALParticipants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
High Hyal Plus inj.
ACTIVE COMPARATORParticipants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks
Interventions
Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huons Co., Ltd.lead
Study Sites (1)
Huons
Ansan-si, Gyeonggi-do, 15588, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
September 8, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2017
Study Completion
April 1, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04