A Controlled Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
brief summary
The goal of this clinical trial is to test HL-01 in patients with knee osteoarthritis pain. The main question\[s\] it aims to answer are: * Measure the change in average daily knee pain intensity scores from baseline to the end of the study using a pain scale that measures pain on a scale of 0 to 10 * Measure the change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scales measuring knee pain, stiffness, and function from baseline to the end of the study * Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study * Measure change of participant and physician assessment of how the target knee pain and function are affected by the condition from baseline to end of the study * Measure how often rescue medication is taken from baseline to end of the study * Assess how well participants tolerate the study medication injection (investigational drug or placebo) * Assess whether there are any adverse reactions or side effects from the study medication injection Participants will be asked to complete the following: * Provide informed consent * Knee X-ray of target knee * Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study * Provide demographic information and their medical/surgical history * Provide blood and urine samples at several timepoints throughout the study * Injection of study medication (investigational drug or placebo) * Complete electronic diaries for the following: * Record average daily knee pain intensity scores during screening to confirm eligibility for the study * Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study * Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and/or the end of the study * Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and/or the end of the study * Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and/or the end of the study
official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of a Solution of High and Low Molecular Weight Sodium Hyaluronate (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis