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
Age is between 40 and 80 years of age
Have symptoms of knee osteoarthritis (OA) for at least 6 months
Meet American College of Rheumatology criteria (clinical and radiological) for knee OA
Body mass index (BMI) is less than or equal to 40 kg/m2
Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details.
Have active infections or target knee conditions that may compromise study drug administration
Have exclusionary lab values determined during Screening
Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee
Parallel
Sodium hyaluronate solution - 3.36%
DrugSodium hyaluronate solution, 3.36%, for intra-articular injection.
Sterile buffered solution
DrugSodium chloride, for intra-articular injection.
Change from Baseline of the average daily pain intensity score.
The average daily (24 hour) pain intensity score will be measured on a numeric rating scale (NRS) ranging from 0 to 10. The Baseline value will be the mean of the daily records over the 7-day period before Day 1.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change in WOMAC function subscale from Baseline to Week 12. The test questions are scored on a 0 to 10 point NRS, with 0 meaning no symptom/difficulty and 10 meaning extreme symptom/difficulty. Each subscale score and the total score will be averaged to provide subscale and total scores between 0 and 10.
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This trial is not recruiting at the moment. You can still explore other options:
