[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570196":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Fosamprenavir-Sodium Alginate (FOS-SA)","EXPERIMENTAL","Eight weeks of:\n\n1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID, at least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart",[13],"Drug: Fosamprenavir Calcium & Sodium Alginate",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral Placebo","PLACEBO_COMPARATOR","Eight weeks of:\n\n15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate administered BID at least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fosamprenavir Calcium & Sodium Alginate","1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo","15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate",[15],[32,33],"Microcrystalline cellulose","Sodium Alginate",[35],{"name":36,"affiliation":5,"role":37},"Nikki Johnston, PhD.","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Ally Lesnick, BSc","CONTACT","414-955-2659","alesnick@mcw.edu",{"name":36,"role":41,"phone":45,"phoneExt":26,"email":46},"414-955-4075","njohnston@mcw.edu",[48],{"facility":5,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Milwaukee","Wisconsin","53226","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-87.90647,43.0389,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":42,"phoneExt":26,"email":43},"Ally Lesnick, BSc.",{"type":37,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Nikki Johnston","Professor","100570196","phase-2-oral-fosamprenavir--sodium-alginate-for-gerd-100570196",false,"NCT06704100","Oral Fosamprenavir + Sodium Alginate for GERD","A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir-Sodium Alginate Administered Orally for 8 Weeks to Patients With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease","Inclusion Criteria:\n\n1. Patient aged 18-65 selected as candidate for anti-reflux surgery by study providers.\n2. Patient has received, and continued having GERD symptoms during, standard-labeled dose, daily, PPI therapy for a minimum of 8 weeks before the Screening Visit.\n3. Patient has a diagnosis of GERD with endoscopy and\u002For pH-metry test within the past two years demonstrating 1 or more of the following:\n\n   1. Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)\n   2. Evidence of pathological acid reflux (pH \\\u003C 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of pH testing\n4. Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization.\n\nExclusion Criteria:\n\n1. Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.\n2. Patient has endoscopically confirmed eosinophilic esophagitis (EE).","ALL","18 Years","64 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The goal of this clinical trial is to learn if study drug Fosamprenavir-Sodium Alginate (FOS-SA) administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD).\n\nThe main questions it aims to answer are:\n\n1. Does FOS-SA significantly improve heartburn severity over the 8-week treatment period\n2. Does FOS-SA significantly improve regurgitation frequency over the 8-week treatment period\n3. Does FOS-SA significantly improve symptoms of persistent GERD over the 8-week treatment period\n\nResearchers will compare FOS-SA to a placebo (a look-alike substance that contains no active drug) to see if FOS-SA works to treat PPI-refractory GERD.\n\nParticipants will:\n\n1. Take FOS-SA or placebo every day BID (twice a day) for 8 weeks\n2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests\n3. Keep a daily diary of their symptoms of persistent GERD",[84,85],"Refractory Gastroesophageal Reflux Disease","Gastroesophageal Reflux Disease",[87,88,89,33,90,91],"PPI-refractory GERD","Proton pump inhibitor refractory gastroesophageal reflux disease","Fosamprenavir","Fosamprenavir-Sodium Alginate","FOS-SA","NOT_YET_RECRUITING","2025-10-02",{"date":95,"type":96},"2025-10-06","ACTUAL",{"date":98,"type":78},"2026-03-01",{"date":100,"type":78},"2028-06-01",{"name":5,"class":6},1]