[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pacira Pharmaceuticals, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100584094","phase-2-a-study-to-assess-safety-and-tolerability-of-pcrx-201-in-subjects-with-painful-osteoarthritis-of-the-knee-100584094",false,"NCT06884865","A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee","A Phase 2, Two-Part, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Tolerability of Enekinragene Inzadenovec (PCRX-201) in Subjects With Painful Osteoarthritis of the Knee","Inclusion Criteria:\n\n* Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions.\n* Subjects must be male or female and 45 to 80 years old, inclusive, at Screening.\n* Subjects must exhibit symptoms associated with osteoarthritis of the index knee for ≥12 months before Screening (subject self-reporting is acceptable).\n* Subjects must have index knee pain for \\>15 days over the last month before Screening (subject self-reporting is acceptable).\n* Subjects must have received 2 or more failed 2 or more therapies: Restricted physical activity as per Osteoarthritis Research Society International (OARSI) core level recommendation, ie, \"structured land-based exercise\" (this may include physical therapy), and failure of an additional type of conservative therapy for OA of the index knee, eg, nonselective NSAIDs or COX-2 inhibitors, in the past 12 months.\n* Subjects must have a body mass index (BMI) ≤40 kg\u002Fm2 at Screening.\n* Subjects must have an index knee examination indicating the index knee and the intended injection site area are free of any signs of local or joint infection at Baseline.\n* Subjects must have an index knee Average Daily Knee Pain (NRS) between ≥5.0 and ≤9.0 at Screening and Baseline.\n* Sexually active subjects of child-bearing potential (SOCBP) and their partners must agree to use effective birth control while in the study\n* Subjects must have active synovitis in the index knee as determined by ultrasound Doppler (Part A only) For Part B, participants must have active synovitis in the index knee as determined by contrast-enhanced MRI.\n* Subjects must exhibit American College of Rheumatology Criteria (clinical and radiological) for osteoarthritis as follows:\n\n  1. Knee pain\n  2. At least 1 of the following:\n\n  i. Age \\>50 years ii. Morning stiffness \\\u003C30 minutes iii. Crepitus on knee motion c. Osteophytes\n* Subjects must have K-L Grade 2, 3, or 4 (Part A) or K-L Grade 2 or 3 (Part B) in the index knee based on X-rays performed during Screening and confirmed by trained radiographers at a central facility before enrollment\n* Subjects need to show the presence of moderate or severe synovitis based on 11-point synovitis score using contrast-enhanced MRI (Part A). For Part B, participants need to show the presence of synovitis ≥5 on the Guermazi synovitis scoring scale using contrast-enhanced MRI to be enrolled.\n\nExclusion Criteria:\n\n* Subjects have any current or prior diagnosis of autoimmune connective tissue disorders, secondary OA conditions, benign synovial tumors, gout\u002Fpseudogout, reactive arthritis, RA, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.\n* Subjects have any active systemic or local infection, including infection of the index knee\n* Subjects are unable to undergo MRI with contrast MRI\n* Subjects with X-ray or MRI exclusionary events\n* Subjects have an unstable index knee joint (eg, torn anterior cruciate ligament) within 12 months of Screening\n* Subjects have used any approved or investigational IA drug\u002Fbiologic in index knee within 6 months of Screening (eg, hyaluronic acid, platelet rich plasma, stem cells, prolotherapy, and amniotic fluid injection)\n* Subjects are receiving or have received any gene therapy treatment (eg, IL-1Ra) in the past 3 years\n* Subjects have used IA steroids ≤3 months before screening\n* For Part B, subjects with any surgery related tot he index knee.\n\nOther protocol-defined criteria apply","ALL","45 Years","80 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is.\n\nResearchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time.\n\nParticipants will be asked to\n\n* Visit the clinic for pretreatment and drug administration\n* Visit the clinic for checkups and tests:\n\n  1. Screening through Week 52: intially weekly, bi-weekly, later monthly\n  2. Week 53 through Week 260 (Year 5): 8 visits throughout the period",[27],"Osteoarthritis (OA) of the Knee",[29,30,31],"gene therapy","Knee Pain Arthritis","Osteoarthritis of the Knee","RECRUITING","2026-08-04",{"date":35,"type":36},"2026-08-07","ACTUAL",{"date":38,"type":36},"2025-02-26",{"date":40,"type":21},"2032-07",{"name":42,"class":43},"Pacira Pharmaceuticals, Inc","INDUSTRY",40,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100477312","innovations-in-genicular-outcomes-registry-100477312","NCT05495334","Innovations in Genicular Outcomes Registry","iGOR","Inclusion Criteria:\n\n1. Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening\n2. Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator\n3. Have access to a smartphone or internet access with a computer\u002Ftablet to complete the questionnaires using the registry application\n\nExclusion Criteria:\n\n1. Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol\n2. Planning to have a surgery other than on the target knee",{"count":53,"type":21},10000,"18 Months","OBSERVATIONAL","The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\]).",[58],"Knee Osteoarthritis","2026-07-21",{"date":61,"type":36},"2026-07-23",{"date":63,"type":36},"2021-09-23",{"date":65,"type":21},"2033-12-30",{"name":42,"class":43},19,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100536933","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-exparel-for-postoperative-analgesia-in-subjects-undergoing-cardiac-surgery-100536933","NCT06271265","Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery","A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery","Inclusion Criteria:\n\nAll of the following inclusion criteria must be met for eligibility:\n\n1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass\n2. Male or female participants from 0 to less than 6 years of age on the day of surgery: 2 years to less than 6 years of age for Part 1; 6 months to less than 2 years of age for Part 2; 0 to less than 6 months of age for Part 3\n3. American Society of Anesthesiologists (ASA) Classes 1 through 4.\n4. Parent\u002Fguardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant.\n5. Parent\u002Fguardian is able to adhere to the study visit schedule and complete all study assessments for the participant.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\nA participant will not be eligible for the study if any of the following exclusion criteria are met:\n\n1. History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications\n2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration\n3. Administration of an IP within 30 days or 5 elimination half-lives of such IP, whichever is longer, prior to IP administration, or planned administration of another IP or procedure during participation in this study\n4. History of preterm birth (before 35 weeks of pregnancy)\n5. History of coagulopathies or immunodeficiency disorders\n6. Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and\u002For procedures\n7. Recent or potential exposure to COVID-19\n8. Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason.\n9. Necessity in delayed wound closure\n10. Informed consent withdrawn before randomization","0 Years","6 Years",{"count":78,"type":21},48,[80],"PHASE1","This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).",[83],"Postoperative Pain",[85,86,87],"Analgesia","Cardiac Surgery","Pediatric","2025-12-19",{"date":90,"type":36},"2025-12-29",{"date":92,"type":36},"2024-03-29",{"date":94,"type":21},"2027-01",{"name":42,"class":43},5,""]