[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655990":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":28,"interventions":41,"overallOfficials":18,"centralContacts":50,"locations":18,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":18},{"fullName":5,"class":6},"IBSA Institut Biochimique SA","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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.","From Baseline to Week 12",[14],{"measure":15,"description":16,"timeFrame":17},"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\u002Fdifficulty and 10 meaning extreme symptom\u002Fdifficulty. Each subscale score and the total score will be averaged to provide subscale and total scores between 0 and 10.","Baseline to Week 12.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","INVESTIGATOR",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"High and Low Molecular Weight Sodium Hyaluronate (HL-01)","EXPERIMENTAL","Patients will receive single intra-articular knee injection of 3.36% HL-01.",[34],"Drug: Sodium hyaluronate solution - 3.36%",{"label":36,"type":37,"description":38,"interventionNames":39},"Sterile buffered solution","PLACEBO_COMPARATOR","Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).",[40],"Drug: Sterile buffered solution",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"DRUG","Sodium hyaluronate solution - 3.36%","Sodium hyaluronate solution, 3.36%, for intra-articular injection.",[30],{"type":43,"name":36,"description":48,"armGroupLabels":49,"otherNames":18},"Sodium chloride, for intra-articular injection.",[36],[51],{"name":52,"role":53,"phone":54,"phoneExt":18,"email":55},"Marta Bignamini","CONTACT","+4 158 360 1666","marta.bignamini@ibsa.ch",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":69,"type":70},704,"ESTIMATED","INTERVENTIONAL",[73],"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",[76],"Osteo Arthritis of the Knee",[78],"Osteoarthritis of the knee","NOT_YET_RECRUITING","2026-10-05",{"date":82,"type":83},"2026-10-07","ACTUAL",{"date":85,"type":70},"2026-09-30",{"date":87,"type":70},"2027-06-30",{"name":5,"class":6}]