[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05658575":3,"trial-entities:NCT05658575":635,"trial-summary:NCT05658575":638},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":46,"primary_purpose":47,"phases":48,"enrollment_info":51,"interventions":54,"primary_outcomes":66,"secondary_outcomes":71,"sex":117,"minimum_age":118,"maximum_age":119,"healthy_volunteers":120,"eligibility_criteria":121,"std_ages":141,"locations":144,"central_contacts":623,"overall_officials":632,"references":633,"see_also_links":634},"NCT05658575","OLT1177-08","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","RECRUITING","2027-01-31","2026-03","2026-03-11","2023-01-06","Olatec Therapeutics, Inc.","INDUSTRY",true,"The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.","This is a multi-center Phase 2\u002F3 randomized, double-blind, placebo-controlled, parallel-group safety and efficacy study of dapansutrile (OLT1177®), a specific NLRP3 inhibitor, conducted in subjects with acute gout flare. Up to 300 eligible subjects will be randomized 2:1 to one of two treatment arms to receive either dapansutrile tablets or matching placebo twice daily for 7 days. An initial loading dose on Study Day 1 will be followed by a twice daily maintenance dosing regimen.\n\nSubjects presenting with acute gout flare that began within 96 hours prior to the Baseline\u002FDay 1 visit will be evaluated for eligibility. Subjects who are determined to be eligible will be randomized into either an active treatment arm (2\u002F3 of the subjects enrolled) or the placebo arm (1\u002F3 of the subjects enrolled).\n\nEligible subjects who are randomized into the study will also be provided with rescue medication at the Baseline\u002FDay 1 Visit. No other pain medications, anti-inflammatory drugs (e.g., steroids or nonsteroidal anti-inflammatory drugs), or treatments for gout flare are allowed during the Treatment Period.\n\nDuring the Treatment Period, subjects will return to the clinic trial site on Day 4 and, following the 7-day Treatment Period, subjects will return to the clinical trial site on Day 8, and then Day 15 with safety data collected through Day 36.",[19,20,21,22,23,24,25],"Acute Gout Flare","Gout Attack","Gout Flare","Gouty Arthritis","Gout","Arthritis","Joint Pain",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"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","INTERVENTIONAL","TREATMENT",[49,50],"PHASE2","PHASE3",{"count":52,"type":53},300,"ESTIMATED",[55,61],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","Dapansutrile","An initial loading dose of 2000 mg dapansutrile on Day 1 followed by a maintenance regimen of 1000 mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive.",[57],[33],{"type":62,"name":63,"description":64,"armGroupLabels":65},"OTHER","Placebo Tablet","An initial loading dose of matching placebo (to mimic dapansutrile dosing) on Day 1 followed by a maintenance regimen of matching placebo twice daily starting 12 hours later through the second dose on Day 7, inclusive.",[63],[67],{"measure":68,"description":69,"timeFrame":70},"To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP","Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.","72 hours",[72,76,80,84,86,90,93,96,100,104,107,110,113],{"measure":73,"description":74,"timeFrame":75},"Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug","Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at specified timepoints up to Day 15 post initial loading dose of study drug. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.","12, 24, 36, 48 and 60 hours; 8 and 15 days",{"measure":77,"description":78,"timeFrame":79},"To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion).","Patient Global Assessment of Response to Treatment (PGART) will be completed by the subject through Day 8. The PGART is a 5-level Likert-type single item (i.e., one general question the Subject is asked to answer) about the overall perceived status of their response to treatment on a scale from \"None\" to \"Excellent\".","4 and 8 days",{"measure":81,"description":82,"timeFrame":83},"To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion)","Change from baseline in the Investigator-assessed Target Joint Score at scheduled assessments through Study Day 15. The Investigator-assessed Target Joint Score is a combined assessment of individual assessments for the following outcome domains: tenderness, swelling, erythema, warmth, and range of motion each with a scale of 0 through 3, with lower scoring in each domain indicating better outcomes in the respective domain.","8 and 15 days",{"measure":77,"description":85,"timeFrame":79},"Investigator Global Assessment of Response to Treatment (IGART) will be completed by the Investigator through Study Day 8. The IGART is a 5-level Likert-type single item (i.e., one general question the Investigator is asked to answer) about the overall perceived status of the subject's response to treatment on a scale from \"None\" to \"Excellent\".",{"measure":87,"description":88,"timeFrame":89},"To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP.","Proportion of subjects with a response (defined as a 20%, 50%, or 70% reduction from baseline without using Rescue Medication) in the subject-assessed pain intensity score (100-mm VAS) in the target joint up to Day 15 post initial loading dose of study drug.","48 and 72 hours; 8 and 15 days",{"measure":77,"description":91,"timeFrame":92},"Change from baseline in the subject-assessed Quality of Life (QoL) questionnaire Short Form Health Survey-12 version 2.0 (SF-12v2) at scheduled assessments through Study Day 15.","15 days",{"measure":87,"description":94,"timeFrame":95},"Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in any actively flaring non-target joint(s) up to Day 15 post initial loading dose of study drug. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.","4, 8 and 15 days",{"measure":97,"description":98,"timeFrame":99},"To characterize the population PK of dapansutrile and exposure-response relationship for efficacy and safety.","Blood samples will be drawn and analyzed in order to characterize the population PK of dapansutrile","up to 15 days",{"measure":101,"description":102,"timeFrame":103},"Physical examinations","Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.","Up to 15 days",{"measure":105,"description":106,"timeFrame":103},"Vital signs","Vital signs consisting of pulse, resting blood pressure, temperature and respirations will be recorded and analyzed for changes throughout the duration of the study",{"measure":108,"description":109,"timeFrame":92},"Electrocardiograms","Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.",{"measure":111,"description":112,"timeFrame":103},"Safety laboratory measurements","Blood samples will be drawn and analyzed for routine chemistry blood markers, routine hematology\u002Fcomplete blood count and routine urinalysis will be performed throughout the duration of the study",{"measure":114,"description":115,"timeFrame":116},"Adverse events","Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.","Up to 36 days","ALL","18 Years",null,false,{"inclusion":122,"exclusion":127,"raw_text":140},[123,124,125,126],"Male and female subjects age 18 or older","Clinical diagnosis of gout according to the 2015 ACR\u002FEULAR Gout Classification Criteria:","Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening\u002FBaseline Visit","Provide written informed consent and understand and comply with all trial requirements",[128,129,130,131,132,133,134,135,136,137,138,139],"Presence of any palpable and visible tophi by physical examination","Has ≥ 4 joints with an acute gout flare at Screening\u002FBaseline","Presence of active rheumatoid arthritis or other acute inflammatory arthritis","Evidence\u002Fsuspicion of infectious\u002Fseptic arthritis","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","Known diagnosis of chronic kidney disease or known history of renal impairment","Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening\u002FBaseline","Active malignancy or recent malignancy with any systemic anti-cancer treatment","Has a hypersensitivity or allergy to OLT1177® or other drugs in its class","Hypersensitivity or allergy to paracetamol\u002Facetaminophen","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","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","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",[142,143],"ADULT","OLDER_ADULT",[145,155,172,184,192,206,220,235,249,263,278,293,307,315,329,338,346,361,368,372,380,395,410,425,433,447,460,471,479,487,498,512,526,540,551,565,576,584,598,612],{"facility":146,"status":147,"city":148,"state":149,"zip":150,"country":151,"geoPoint":152},"University of Alabama at Birmingham","WITHDRAWN","Birmingham","Alabama","35294","United States",{"lat":153,"lon":154},33.52066,-86.80249,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":151,"contacts":160,"geoPoint":169},"Arizona Arthritis & Rheumatology Associates - Glendale","Glendale","Arizona","85306",[161,166],{"name":162,"role":163,"phone":164,"email":165},"Rebecca Martinez","CONTACT","480-350-7655","rebecca.martinez@azarthritis.com",{"name":167,"role":168},"Mona Amin, MD","PRINCIPAL_INVESTIGATOR",{"lat":170,"lon":171},33.53865,-112.18599,{"facility":173,"status":8,"city":174,"state":158,"zip":175,"country":151,"contacts":176,"geoPoint":181},"Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa","Mesa","85210",[177,179],{"name":178,"role":163,"phone":164,"email":165},"Rebecca 480-350-7655",{"name":180,"role":168},"Swati Bharadwaj, MD",{"lat":182,"lon":183},33.42227,-111.82264,{"facility":185,"status":147,"city":186,"state":187,"zip":188,"country":151,"geoPoint":189},"American Institute of Research","Los Angeles","California","90017",{"lat":190,"lon":191},34.05223,-118.24368,{"facility":193,"status":8,"city":194,"state":187,"zip":195,"country":151,"contacts":196,"geoPoint":203},"TriWest Research Associates","San Diego","92108",[197,201],{"name":198,"role":163,"phone":199,"email":200},"Lennette Fontelar","619-334-4735","lfontelar@triwestresearch.com",{"name":202,"role":168},"Arthur Ray Mabaquiao, MD",{"lat":204,"lon":205},32.71571,-117.16472,{"facility":207,"status":8,"city":208,"state":187,"zip":209,"country":151,"contacts":210,"geoPoint":217},"Valiance Clinical Research - Tarzana","Tarzana","91356",[211,215],{"name":212,"role":163,"phone":213,"email":214},"Gail Ma","818-938-9167","g.ma@valianceclinicalresearch.com",{"name":216,"role":168},"Richard Park, MD",{"lat":218,"lon":219},34.17334,-118.55397,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":151,"contacts":225,"geoPoint":232},"Hillcrest Medical Research","DeLand","Florida","32720",[226,230],{"name":227,"role":163,"phone":228,"email":229},"Larry Moulder","321-999-7616","lmoulder@hillcrestmedicalresearch.com",{"name":231,"role":168},"John Hill, MD",{"lat":233,"lon":234},29.02832,-81.30312,{"facility":236,"status":8,"city":237,"state":223,"zip":238,"country":151,"contacts":239,"geoPoint":246},"SIMEDHealth","Gainesville","32607,",[240,244],{"name":241,"role":163,"phone":242,"email":243},"Brandy Donahue-Quails","352-333-3885","Bdonahue-quails@simedresearch.com",{"name":245,"role":168},"Timothy H Elder, MD",{"lat":247,"lon":248},29.65163,-82.32483,{"facility":250,"status":8,"city":251,"state":223,"zip":252,"country":151,"contacts":253,"geoPoint":260},"University of Florida Health Jacksonville","Jacksonville","32256",[254,258],{"name":255,"role":163,"phone":256,"email":257},"Shannon Lloyd","904-633-0071","shannon.lloyd@ufhealth.org",{"name":259,"role":168},"Gurjit Kaeley, MD",{"lat":261,"lon":262},30.33218,-81.65565,{"facility":264,"status":8,"city":265,"state":223,"zip":266,"country":151,"contacts":267,"geoPoint":275},"Well Pharma Medical Research","Miami","33173",[268,273],{"name":269,"role":163,"phone":270,"phoneExt":271,"email":272},"Ramon Perez Landaburo","305-665-4818","231","rperez@wpharma.com",{"name":274,"role":168},"Eddie Armas, MD",{"lat":276,"lon":277},25.77427,-80.19366,{"facility":279,"status":8,"city":280,"state":223,"zip":281,"country":151,"contacts":282,"geoPoint":290},"Clinical Research of West Florida","Tampa","33765",[283,288],{"name":284,"role":163,"phone":285,"phoneExt":286,"email":287},"Jocelyn Evans","813-870-1292","129","jevans@crwf.com",{"name":289,"role":168},"Lon Lynn, MD",{"lat":291,"lon":292},27.94752,-82.45843,{"facility":294,"status":8,"city":237,"state":295,"zip":296,"country":151,"contacts":297,"geoPoint":304},"Arthritis Center of North Georgia - Gainesville","Georgia","30501",[298,302],{"name":299,"role":163,"phone":300,"email":301},"Cindy Valenzuela","770-531-3711","cvalenzuela@southeasternra.com",{"name":303,"role":168},"Brent Flickinger, MD",{"lat":305,"lon":306},34.29788,-83.82407,{"facility":308,"status":147,"city":309,"state":310,"zip":311,"country":151,"geoPoint":312},"Great Lakes Clinical Trials","Chicago","Illinois","60640",{"lat":313,"lon":314},41.85003,-87.65005,{"facility":316,"status":8,"city":317,"state":310,"zip":318,"country":151,"contacts":319,"geoPoint":326},"Advanced Quality Medical Research","Orland Park","60462",[320,324],{"name":321,"role":163,"phone":322,"email":323},"Selahaddin Hocaoglu","312-823-6800","selahaddin@m1-health.com",{"name":325,"role":168},"Dennis Levinson, MD",{"lat":327,"lon":328},41.63031,-87.85394,{"facility":330,"status":331,"city":332,"state":333,"zip":334,"country":151,"geoPoint":335},"The Research Group of Lexington","ACTIVE_NOT_RECRUITING","Lexington","Kentucky","40503",{"lat":336,"lon":337},37.98869,-84.47772,{"facility":339,"status":147,"city":340,"state":341,"zip":342,"country":151,"geoPoint":343},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":344,"lon":345},42.27756,-83.74088,{"facility":347,"status":8,"city":348,"state":349,"zip":350,"country":151,"contacts":351,"geoPoint":358},"Montana Medical Research","Missoula","Montana","59808",[352,356],{"name":353,"role":163,"phone":354,"email":355},"Eve Hickey","406-549-1124","ehickey@montanamedicalresearch.com",{"name":357,"role":168},"Clancy Cone, MD",{"lat":359,"lon":360},46.87215,-113.994,{"facility":362,"status":331,"city":363,"state":363,"zip":364,"country":151,"geoPoint":365},"NYU Langone","New York","10016",{"lat":366,"lon":367},40.71427,-74.00597,{"facility":369,"status":147,"city":363,"state":363,"zip":370,"country":151,"geoPoint":371},"IMA Clinical Research - Manhattan","10036",{"lat":366,"lon":367},{"facility":373,"status":147,"city":374,"state":375,"zip":376,"country":151,"geoPoint":377},"Altoona Research","Duncansville","Pennsylvania","16635",{"lat":378,"lon":379},40.42341,-78.4339,{"facility":381,"status":8,"city":382,"state":383,"zip":384,"country":151,"contacts":385,"geoPoint":392},"Lower Country Rheumatology - Summerville","Summerville","South Carolina","29486",[386,390],{"name":387,"role":163,"phone":388,"email":389},"Eleanor Gardzalla","843-572-4840","egardzalla@articularishealthcare.com",{"name":391,"role":168},"Jennifer Murphy, MD",{"lat":393,"lon":394},33.0185,-80.17565,{"facility":396,"status":8,"city":397,"state":398,"zip":399,"country":151,"contacts":400,"geoPoint":407},"Amarillo Center of Clinical Research","Amarillo","Texas","79124",[401,405],{"name":402,"role":163,"phone":403,"email":404},"Vallen White","806-352-2453","vwhite@allergyarts.com",{"name":406,"role":168},"Constantine Saadeh, MD",{"lat":408,"lon":409},35.222,-101.8313,{"facility":411,"status":8,"city":412,"state":413,"zip":414,"country":151,"contacts":415,"geoPoint":422},"Utah Health - University of Utah Hospital","Salt Lake City","Utah","84108",[416,420],{"name":417,"role":163,"phone":418,"email":419},"Julieanne Hall","801-213-1558","julieanne.hall@hsc.utah.edu",{"name":421,"role":168},"Naomi Schlessinger, MD",{"lat":423,"lon":424},40.76078,-111.89105,{"facility":426,"status":147,"city":427,"state":428,"zip":429,"country":151,"geoPoint":430},"Clinical Trial Site","Bothell","Washington","98021",{"lat":431,"lon":432},47.76232,-122.2054,{"facility":434,"status":8,"city":435,"state":428,"zip":436,"country":151,"contacts":437,"geoPoint":444},"Arthritis Northwest","Spokane","99204",[438,442],{"name":439,"role":163,"phone":440,"email":441},"Terri Cone","509-838-6500","tcone@arthritisnw.com",{"name":443,"role":168},"Christopher Wright, MD",{"lat":445,"lon":446},47.65966,-117.42908,{"facility":448,"status":8,"city":449,"zip":450,"country":451,"contacts":452,"geoPoint":457},"Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin","Bordeaux","33076","France",[453,455],{"name":454,"role":163},"Clinical Contact",{"name":456,"role":168},"Marie-Elise Truchetet, MD",{"lat":458,"lon":459},44.84124,-0.58046,{"facility":461,"status":8,"city":462,"zip":463,"country":451,"contacts":464,"geoPoint":468},"Hôpital Saint Philibert","Lomme","59462",[465,466],{"name":454,"role":163},{"name":467,"role":168},"Tristan Pascart, MD",{"lat":469,"lon":470},50.64358,2.98715,{"facility":472,"status":8,"city":473,"country":451,"contacts":474,"geoPoint":476},"Hôpital Lariboisière","Paris",[475],{"name":454,"role":163},{"lat":477,"lon":478},48.85341,2.3488,{"facility":480,"status":8,"city":481,"country":451,"contacts":482,"geoPoint":484},"CHU de Rouen - Hôpital Charles-Nicolle","Rouen",[483],{"name":454,"role":163},{"lat":485,"lon":486},49.44313,1.09932,{"facility":488,"status":8,"city":489,"country":490,"contacts":491,"geoPoint":495},"Emek Medical Center","Afula","Israel",[492,493],{"name":454,"role":163},{"name":494,"role":168},"Amir Bieber, MD",{"lat":496,"lon":497},32.60907,35.2892,{"facility":499,"status":8,"city":500,"zip":501,"country":490,"contacts":502,"geoPoint":509},"Carmel Medical Center","Haifa","3436212",[503,507],{"name":504,"role":163,"phone":505,"email":506},"Noga Cohen","(+972)5240434341","nogacoh@clalit.org.il",{"name":508,"role":168},"Devy Zisman, MD",{"lat":510,"lon":511},32.81303,34.99928,{"facility":513,"status":8,"city":514,"zip":515,"country":490,"contacts":516,"geoPoint":523},"Rabin Medical Center - Beilinson and Hasharon","Petah Tikva","49100",[517,521],{"name":518,"role":163,"phone":519,"email":520},"Yosra Khateb","(+972)39377105","yusrakha@clalit.org.il",{"name":522,"role":168},"Elisheva Pokroy-Shapira, MD",{"lat":524,"lon":525},32.08707,34.88747,{"facility":527,"status":8,"city":528,"zip":529,"country":490,"contacts":530,"geoPoint":537},"The Chaim Sheba Medical Center","Ramat Gan","5266202",[531,535],{"name":532,"role":163,"phone":533,"email":534},"Revital Nawi","(+972)526668127","revital.nawi@sheba.health.gov.il",{"name":536,"role":168},"Howard Amital, MD",{"lat":538,"lon":539},32.08227,34.81065,{"facility":541,"status":8,"city":542,"country":543,"contacts":544,"geoPoint":548},"Reade Research BV","Amsterdam","Netherlands",[545,546],{"name":454,"role":163},{"name":547,"role":168},"Martijn Gerritsen, MD",{"lat":549,"lon":550},52.37403,4.88969,{"facility":552,"status":8,"city":553,"zip":554,"country":543,"contacts":555,"geoPoint":562},"Maastricht Universitair Medisch Centrum","Maastricht","6229 HX",[556,560],{"name":557,"role":163,"phone":558,"email":559},"Christel Mertens","(+31)0433072099","christel.mertens@mumc.nl",{"name":561,"role":168},"Caroline Van Durme, MD",{"lat":563,"lon":564},50.84833,5.68889,{"facility":566,"status":8,"city":567,"country":543,"contacts":568,"geoPoint":573},"VieCuri Medisch Centrum","Venlo",[569,571],{"name":570,"role":163},"Clinical Site",{"name":572,"role":168},"Tim Jansen, MD",{"lat":574,"lon":575},51.37,6.16806,{"facility":577,"status":147,"city":578,"zip":579,"country":580,"geoPoint":581},"Hospital Universitario san Juan de Alicante","Alicante","03010","Spain",{"lat":582,"lon":583},38.34517,-0.48149,{"facility":585,"status":8,"city":586,"zip":587,"country":580,"contacts":588,"geoPoint":595},"Hospital de la Santa Creu i Sant Pau","Barcelona","08025",[589,593],{"name":590,"role":163,"phone":591,"email":592},"Júlia Bernárdez","(+34)935537112","JBernardez@santpau.cat",{"name":594,"role":168},"Cesar Diaz Torne, MD",{"lat":596,"lon":597},41.38879,2.15899,{"facility":599,"status":8,"city":600,"zip":601,"country":580,"contacts":602,"geoPoint":609},"Hospital Universitario de La Princesa","Madrid","28006",[603,607],{"name":604,"role":163,"phone":605,"email":606},"Helena Vazquez","(+34)915202473","helena.vazquez@salud.madrid.org",{"name":608,"role":168},"Esther Vicente Rabaneda, MD",{"lat":610,"lon":611},40.4165,-3.70256,{"facility":613,"status":8,"city":600,"zip":614,"country":580,"contacts":615,"geoPoint":622},"Hospital Universitario Infanta Leonor","28031",[616,620],{"name":617,"role":163,"phone":618,"email":619},"Pedro Torres","(+34)676146368","pedro.a.torresgomez.sc@gmail.com",{"name":621,"role":168},"Enrique Calvo Aranda, MD",{"lat":610,"lon":611},[624,629],{"name":625,"role":163,"phone":626,"phoneExt":627,"email":628},"Philip Piscitelli","+1 833-652-8321","115","phil.piscitelli@olatec.com",{"name":630,"role":163,"email":631},"Clinical Operations","clinops@olatec.com",[],[],[],{"nct_id":4,"conditions":636,"biomarkers":637},[23],[],{"nct_id":4,"found":15,"summary":639,"prompt_version":649},{"design":640,"status":641,"heading":642,"summary":643,"follow_up":644,"word_count":645,"commitments":646,"compensation":647,"drugs_mentioned":648},"This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either dapansutrile or a placebo, and neither you nor your doctor will know which you are receiving. About 300 participants will be enrolled.","completed","Study of Dapansutrile for Acute Gout Flares","This study is testing a medication called dapansutrile to see if it can effectively reduce joint pain during an acute gout flare (a sudden, severe attack of gout). You may be eligible if you are 18 or older and have a confirmed diagnosis of gout, including evidence of gout crystals in your joint fluid or imaging. The study will compare dapansutrile to a placebo (an inactive pill that looks like the study drug) to see if dapansutrile helps more with pain at 72 hours after starting treatment. Up to 300 people will participate. The current status of this study is unclear.","Safety data will be collected through Day 36 after treatment begins.",101,"You would take dapansutrile or placebo tablets for 7 days, starting with a loading dose and then twice daily. You would also have clinic visits on Day 4, Day 8, and Day 15.","Not stated in the trial record.",[57],"v2"]