[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592910":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":40,"overallStatus":55,"whyStopped":40,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanism Guided Strategy","ACTIVE_COMPARATOR","1\\) 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.\n\n1. Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.\n2. Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.\n3. Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.",[13,14,15],"Drug: Omeprazole 40 MG","Behavioral: Laryngeal Recalibration Therapy","Behavioral: GERD Lifestyle Recommendations",{"label":17,"type":10,"description":18,"interventionNames":19},"Usual Care Strategy","1\\) an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.",[13,15],[21,29,36],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Omeprazole 40 MG","8 week double dose therapy of proton pump inhibitor or placebo.",[9,17],[27,28],"Prilosec","NDA 21-229",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Laryngeal Recalibration Therapy","LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. Each session with the SLP will guide subjects through these therapies. The existing script-based LRT protocol consists of the following: 1) mechanical guidance (laryngeal suppression, voice production, breath coordination), 2) cognitive guidance (identification of thinking patterns, recalibration of thoughts about laryngeal sensations).",[9],[35],"LRT",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"GERD Lifestyle Recommendations","This is the typical lifestyle recommendations for GERD used clinically.",[9,17],null,[42],{"name":43,"affiliation":44,"role":45},"Rena Yadlapati, MD","UC San Diego Health","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},"Lorijane Robles","CONTACT","858-246-5236","esophagealresearch@health.ucsd.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":40,"geoPoint":40,"contacts":61},"University of California San Diego","RECRUITING","San Deigo","California","92093","United States","US",[62],{"name":63,"role":49,"phone":64,"phoneExt":40,"email":65},"Esophageal Clinical Research Coordinator","858-822-0391","lnrobles@health.ucsd.edu",{"type":45,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Rena Yadlapati","Professor of Medicine",[70],{"name":71,"class":72},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100592910","phase-4-the-mechanism-versus-ppi-trial-100592910",false,"NCT06999577","The Mechanism Versus PPI Trial","The MVP Trial: A Randomized Controlled Trial of Mechanism Guided vs PPI Strategy for Laryngopharyngeal Reflux","MVP","Inclusion Criteria:\n\n1. 18-89 years of age\n2. \\>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)\n3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression\n4. Off acid suppression therapy for at least 2 weeks prior to randomization.\n\nExclusion Criteria:\n\n1. PPI intolerance and\u002For known hypersensitivity to the formulation or substituted benzimidazoles\n2. History of foregut surgery\n3. Known diagnosis of achalasia\n4. Inability to fast for 4 hours (no food or drink)\n5. Active tobacco use\n6. Pregnant or breastfeeding\n7. Unable to consent in English or Spanish\n8. Unable to provide consent without a legal guardian or representative\n9. Imprisoned\n10. Endoscopic findings conclusive with esophageal mucosal abnormalities\n11. Unable to proceed with reflux monitoring\n12. Use of acid suppression during the reflux monitoring and\u002For before the study medication (omeprazole or placebo) is dispensed\n13. Prior LRT for reflux related symptoms\n14. History of major psychiatric comorbidity\n15. Unable to attend in person study visits at UCSD","ALL","18 Years","89 Years",{"count":85,"type":86},160,"ESTIMATED","INTERVENTIONAL",[89],"PHASE4","The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients.\n\nThe main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants?\n\nIf there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups.\n\nParticipants will be be asked to do the following:\n\n* participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy\n* take an oral capsule daily (omeprazole 40mg or placebo)\n* come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider\n* consider incorporating recommended lifestyle modifications\n* complete weekly surveys",[92,93,94,95,96],"Laryngopharyngeal Reflux","Cough","Throat Clearing","Dysphonia","Reflux","2025-07-29",{"date":99,"type":100},"2025-08-01","ACTUAL",{"date":102,"type":100},"2025-06-04",{"date":104,"type":86},"2029-07-01",{"name":5,"class":6},1]