[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gout-attack\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gout-attack":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100489857","phase-2-study-of-dapansutrile-tablets-in-subjects-with-an-acute-gout-flare-100489857",false,"NCT05658575","Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","A Multi-Center Phase 2\u002F3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","Inclusion Criteria:\n\n* Male and female subjects age 18 or older\n* Clinical diagnosis of gout according to the 2015 ACR\u002FEULAR Gout Classification Criteria:\n\nA) Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening\u002FBaseline Visit\u002FStudy Day 1, or\n\nB) Documented history in the target joint or bursa ; or documented history of 2 or more gout flares in the previous 18 months\n\n* Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening\u002FBaseline Visit\n* Provide written informed consent and understand and comply with all trial requirements\n\nExclusion Criteria:\n\n* Presence of any palpable and visible tophi by physical examination\n* Has ≥ 4 joints with an acute gout flare at Screening\u002FBaseline\n* Presence of active rheumatoid arthritis or other acute inflammatory arthritis\n* Evidence\u002Fsuspicion of infectious\u002Fseptic arthritis\n* Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint\n* Known diagnosis of chronic kidney disease or known history of renal impairment\n* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening\u002FBaseline\n* Active malignancy or recent malignancy with any systemic anti-cancer treatment\n* Has a hypersensitivity or allergy to OLT1177® or other drugs in its class\n* Hypersensitivity or allergy to paracetamol\u002Facetaminophen\n* Use of any prohibited concomitant medications\u002Ftherapies over the periods defined in the protocol or planned use of any prohibited concomitant medications\u002Ftherapies during the Treatment Period (including the use of paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or other pain medications within 12 hours prior to the Screening\u002F Baseline Visit\n* Use of any product containing paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication \\[paracetamol\u002Facetaminophen\\], which is permitted after completion of the first target joint pain assessment on Study Day 4","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.",[27,28,29,30,31,32,33],"Acute Gout Flare","Gout Attack","Gout Flare","Gouty Arthritis","Gout","Arthritis","Joint Pain",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"gout","gouty arthritis","mono-articular arthritis","NLRP3","NLRP3 inhibitor","dapansutrile","OLT1177","joint pain","inflammation","gouty Inflammation","inflammasomes","IL-1 beta","IL-1 inflammation","autoinflammatory conditions","hyperuricemia","uric acid crystal","flare","small-molecule","therapeutic","RECRUITING","2026-03-09",{"date":57,"type":58},"2026-03-11","ACTUAL",{"date":60,"type":58},"2023-01-06",{"date":62,"type":20},"2027-01-31",{"name":64,"class":65},"Olatec Therapeutics LLC","INDUSTRY",40,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":91},"100582468","phase-3-efficacy-anda-safety-of-etoricoxib-with-betamethasone-for-the-treatment-of-acute-gout-arthritis-100582468","NCT06863701","Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis","Efficacy and Safety Study for the Combination of Etoricoxib \u002F Betamethasone Compared to Etoricoxib for the Treatment of Patients Diagnosed With Acute Gout Arthritis","Inclusion Criteria:\n\n* Willing to participate in the study and provide written informed consent.\n* Women of childbearing potential and sexually active must use an acceptable contraceptive method (barrier and\u002For hormonal) as determined by the investigator.\n* History of hyperuricemia diagnosis (uric acid \\> 7 mg\u002FdL) reported in medical history or patient interview.\n* Clinical diagnosis of acute gouty arthritis with a score of at least 4 based on the following criteria: Male (2 points), history of a similar episode (2 points), symptom onset within the last 24 hours (0.5 points), joint redness (1 point), involvement of the first metatarsophalangeal joint (2.5 points), and hypertension or at least one cardiovascular disease (1.5 points).\n* Acute episode characterized by severe pain, inflammation, edema, and erythema in the affected joint (≤ 48 hours before study inclusion).\n* In the opinion of the Principal Investigator or treating physician, the patient is eligible for treatment with the investigational product and may benefit clinically\n\nExclusion Criteria:\n\n* Patients participating in another clinical study involving an investigational treatment or participation in one within the two weeks prior to study initiation.\n* Patients whose participation in the study may be influenced (e.g., employment relationship with the research center or sponsor, vulnerable populations, etc.).\n* In the investigator's judgment, any condition that affects prognosis and prevents outpatient management, which must be assessed by the principal investigator to determine the patient's eligibility.\n* History of severe, progressive, or unstable advanced disease of any kind that may interfere with efficacy and safety evaluations or put the patient at risk.\n* Pregnant or breastfeeding patients.\n* The study medication is contraindicated for medical reasons.\n* History of intolerance or allergic reaction to NSAIDs (nonsteroidal anti-inflammatory drugs), paracetamol, or known hypersensitivity to any component of the formulation.\n* Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, gastrointestinal bleeding, etc.).\n* History of congestive heart failure (NYHA classification II-IV), established ischemic heart disease, peripheral arterial disease, and\u002For cerebrovascular disease (including patients who have recently undergone coronary revascularization or angioplasty).\n* Treatment with systemic corticosteroids for the management of acute gouty arthritis within two weeks before study initiation.\n* Treatment with NSAIDs within 48 hours prior to study initiation, except for aspirin at cardioprotective doses.\n* History of treatment failure with selective COX-2 inhibitors, as reported in medical history or patient interview.\n* Presence of acute polyarticular gout affecting more than four joints.\n* History of alcohol or drug abuse within the past year.\n* Clinical suspicion of joint infection or another joint disease different from acute gouty arthritis.\n* History of chronic liver failure (Child-Pugh A, B, and\u002For C), as reported in medical history or patient interview.\n* History of chronic renal failure (glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m²), as reported in medical history or patient interview.\n* Significant history of known coagulation disorders (e.g., Von Willebrand disease, hemophilia, vitamin K deficiency, etc.) or use of anticoagulants, as reported in medical history or patient interview.\n* Oncology patients (except for basal cell skin cancer) or patients with severe diseases that, in the investigator's opinion, have a severe prognosis or a life expectancy of less than one year, as well as patients with mental illnesses.\n* Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, shortness of breath) and\u002For contact within the last 14 days with a suspected or confirmed COVID-19 case.",{"count":75,"type":20},72,[24],"Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the Fixed-Dose Combination of Etoricoxib\u002FBetamethasone Versus Etoricoxib in Patients With Acute Gouty Arthritis",[79,28],"Gout Arthritis",[79,28,81,82],"Etoricoxib","Betamethasone","2025-04-01",{"date":85,"type":58},"2025-04-03",{"date":87,"type":58},"2025-01-27",{"date":62,"type":20},{"name":90,"class":65},"Laboratorios Silanes S.A. de C.V.",1]