A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
NCT ID: NCT02893098
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
232 participants
INTERVENTIONAL
2016-08-31
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis
NCT03484091
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03122860
Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
NCT06399042
Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
NCT01510535
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
NCT02536833
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Humia inj.
Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
Humia inj.
Single injection of 3mL Humia inj.
Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
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
High hyal Plus inj.
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huons Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huons
Ansan-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HU-025 P3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.