[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-gastroesophageal-reflux-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-gastroesophageal-reflux-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"Refractory Gastroesophageal Reflux Disease","Gastroesophageal Reflux Disease",[30,31,32,33,34,35],"PPI-refractory GERD","Proton pump inhibitor refractory gastroesophageal reflux disease","Fosamprenavir","Sodium Alginate","Fosamprenavir-Sodium Alginate","FOS-SA","NOT_YET_RECRUITING","2025-10-02",{"date":39,"type":40},"2025-10-06","ACTUAL",{"date":42,"type":21},"2026-03-01",{"date":44,"type":21},"2028-06-01",{"name":46,"class":47},"Medical College of Wisconsin","OTHER"]