[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IBSA Institut Biochimique SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100655990","phase-3-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-100655990",false,"NCT07819461","A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis","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","Inclusion Criteria:\n\n* Age is between 40 and 80 years of age\n* Have symptoms of knee osteoarthritis (OA) for at least 6 months\n* Meet American College of Rheumatology criteria (clinical and radiological) for knee OA\n* Body mass index (BMI) is less than or equal to 40 kg\u002Fm2\n* Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3\n* Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications\n* The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees\n* Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study\n* Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study\n* Must use a highly effective birth control method if sexually active\n\nExclusion Criteria:\n\n* 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.\n* Have active infections or target knee conditions that may compromise study drug administration\n* Have exclusionary lab values determined during Screening\n* Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee\n* Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions\n* Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety\n* Received another clinical trial therapy, medication, or product with 90 days of Screening\n* Have non-compliance with study diaries during Screening\n* Involved in litigation, disability, or worker's compensation matters based on OA pain\n* Allergic to study drug, HA, placebo, or acetaminophen","ALL","40 Years","80 Years",{"count":20,"type":21},704,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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:\n\n* 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\n* 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\n* Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study\n* 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\n* Measure how often rescue medication is taken from baseline to end of the study\n* Assess how well participants tolerate the study medication injection (investigational drug or placebo)\n* Assess whether there are any adverse reactions or side effects from the study medication injection\n\nParticipants will be asked to complete the following:\n\n* Provide informed consent\n* Knee X-ray of target knee\n* Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study\n* Provide demographic information and their medical\u002Fsurgical history\n* Provide blood and urine samples at several timepoints throughout the study\n* Injection of study medication (investigational drug or placebo)\n* Complete electronic diaries for the following:\n\n  * Record average daily knee pain intensity scores during screening to confirm eligibility for the study\n  * Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study\n  * Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and\u002For the end of the study\n  * Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and\u002For the end of the study\n  * Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and\u002For the end of the study",[27],"Osteo Arthritis of the Knee",[29],"Osteoarthritis of the knee","NOT_YET_RECRUITING","2026-10-05",{"date":33,"type":34},"2026-10-07","ACTUAL",{"date":36,"type":21},"2026-09-30",{"date":38,"type":21},"2027-06-30",{"name":40,"class":41},"IBSA Institut Biochimique SA","INDUSTRY",""]