[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"laryngopharyngeal-reflux\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:laryngopharyngeal-reflux":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100391920","phase-2-fosamprenavir-for-laryngopharyngeal-upper-airway-tissue-treatment-and-enzyme-reduction-100391920",false,"NCT04383262","Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction","A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy of Oral Fosamprenavir for Laryngopharyngeal Reflux","FLUTTER","1\\. Clinical diagnosis of LPR 2. Age ≥ 18 years 3. RSI \\> 13 4. RFS \\> 7 5. Documented LPR by MII-pH testing (\\> 1 proximal event) 6. Failed 3 month bid PPI therapy 7. Attending laryngology clinic with study providers, and having flexible laryngoscopy and MII-pH testing per routine clinical care with a minimum of three months between clinic visits (standard practice) 8. For continued participation after ATRU V1\u002FV2:\n\n1. Hepatic Function Panel must be within normal limits\n2. Results from V1 safety labs must all be within normal limits\n3. Patient agrees not to make any changes to their usual diet and\u002For anti-reflux medications during the study.\n4. Patient is compliant with eDiary completion; that is, they have completed the eDiary questions on at least 5 days each week during the 14 calendar days before the start of the Treatment Period.\n5. Patient is compliant with continuing any current PPI (if using) during the 14 calendar days before the start of the Treatment Period. Patients are considered compliant if, as reported in the daily eDiary, they continued taking their current PPI (if using) on at least 5 days each week during the 14 calendar days before the start of the Treatment Period.\n\n   4.2 EXCLUSION CRITERIA 1. Age ≥ 65 years 2. Patient is not fluent and literate in English. 3. Pregnant (or plan to be) and nursing mothers 4. Women of child-bearing potential not willing to comply with contraceptive requirements during the study treatment and for 1 week following the last dose of study drug.\n\n   o Definition of women of child-bearing potential\n\n   Non-post-menopausal female, who has not had a bilateral oophorectomy or medically documented ovarian failure. A subject may be considered to be post-menopausal when there is either:\n\n   \\- twelve (12) months of spontaneous amenorrhea or;\n\n   \\- six (6) months of spontaneous amenorrhea with serum FSH levels \\> 40 mIU\u002FmL or;\n\n   \\- six (6) weeks postsurgical bilateral oophorectomy with or without hysterectomy.\n\n   A female who has had a tubal ligation sterilization or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g., egg donation, participation in in vitro fertilization).\n   * Contraceptive requirements Fosamprenavir may decrease the effectiveness of combined hormonal contraception through significant CYP3A4 induction of estrogen. If subjects' preferred choice of contraception is combined hormonal contraception, subjects must also agree to use a second method of contraception (condom + spermicide) during study drug treatment.\n\n   Other acceptable highly effective forms of contraception include:\n   * Medroxyprogesterone acetate injectable\n   * Intrauterine Device\n   * Female Sterilization\n   * Male Sterilization 4. Currently being treated with another investigational medical device and\u002For drug 5. A history of gastric or esophageal surgery 6. Gastrointestinal disease that might interfere symptom questionnaire, e.g. inflammatory bowel syndrome 7. A history of laryngeal or neck surgery including thyroidectomy and laryngomicroscopic surgery 8. Suspected esophageal cancer 9. Nasopharyngeal cancer 10. Previously undergone anti-reflux surgery 11. Polypharmacy (five or more concurrent medications due to comorbidities) 12. Any contraindications to FOS including the following:\n\na. Patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome) to any of the components of this product or to amprenavir.\n\nb. Patients taking any drugs that are highly dependent on cytochrome P450 (CYP)3A4 for clearance and for which elevated plasma concentrations are associated with serious and\u002For life-threatening events. Specifically i. Alpha 1-adrenoreceptor antagonist: Alfuzosin ii. Antimycobacterial: Rifampin iii. Antipsychotic: pimozide iv. Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine v. GI motility agent: Cisapride vi. Herbal product: St. John's wort ( Hypericum perforatum) vii. Lipid modifying agents: Lomitapide, lovastatin, simvastatin viii. Non-nucleoside reverse transcriptase inhibitor: Delavirdine ix. PDE5 inhibitor: Sildenafil (Revatio) x. Sedative\u002Fhypnotics: Midazolam, triazolam 13. Patients not willing to avoid eating grapefruit and Seville oranges for five days prior to the first day of dosing study drug through the final study visit.\n\n14\\. Patients taking any of the prohibited medications or foods listed in Section 5.6.3 15. Anticipated poor understanding or compliance of the study protocol 16. History of hepatic impairment 17. Sulfa Allergy 18. Hemophilia 19. Active tuberculosis (TB) or history of active TB. 20. History of latent TB (e.g., positive QuantiFERON-TB test) without history of active TB unless the subject has completed a documented course of prophylactic treatment.\n\n21\\. History of human immunodeficiency virus (HIV) infection or positive for HIV 22. . Patients positive for hepatitis (Seropositive for hepatitis B surface antigen \\[HBsAg\\] or Hepatitis C virus \\[HCV\\] RNA positive) or taking HCV protease inhibitors such as boceprevir, simeprevir and paritaprevir 23. Not willing to refrain from taking biotin containing supplement for at least 12 hours before Visit 1.\n\n24\\. Patient has an acute or chronic condition that, in the Investigator's opinion, would limit the patient's ability to complete or participate in this clinical study.\n\n25\\. Additionally, subjects without the following will be excluded:\n\n1. Ownership of an electronic with access to internet websites and email required to conduct the DRSD, PGI-S, and PGI-C\n2. Internet access\n3. A valid email address for notifications","ALL","18 Years","64 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer. More than 20% of the people in the United States are estimated to have LPR, yet there is no effective medication approved to treat it. Drugs called proton pump inhibitors (PPIs) are often used to treat LPR, even though they were designed for stomach acid problems. These medications reduce acid but do not stop reflux from happening, so they often do not help LPR patients. Despite poor results, PPIs are widely prescribed, are very costly, and can cause side effects.\n\nResearch shows that a digestive enzyme called pepsin plays a key role in LPR. Pepsin can damage the throat and voice box even when acid is not present. Laboratory studies found that certain HIV medications can block damage caused by pepsin. People taking these medications for HIV appear to have a much lower rate of LPR. This study will test fosamprenavir, an FDA-approved HIV drug, as a treatment for LPR. We will conduct a 14-week, double-blind, placebo-controlled clinical trial in patients with LPR who did not improve with standard treatment. Participants will receive either fosamprenavir or placebo, randomly, and symptoms will be measured before and after treatment using standard questionnaires and daily symptom tracking.\n\nBecause there is no effective medical treatment for LPR. this study aims to test a safe, existing drug that targets the underlying cause of the disease.",[28],"Laryngopharyngeal Reflux","NOT_YET_RECRUITING","2026-04-27",{"date":32,"type":33},"2026-05-01","ACTUAL",{"date":35,"type":22},"2026-05-15",{"date":37,"type":22},"2027-10-01",{"name":39,"class":40},"Medical College of Wisconsin","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100621009","comprehensive-analysis-of-the-swallowing-mechanism-using-high-resolution-manometry-with-impedance-100621009","NCT07365046","Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance","Inclusion Criteria:\n\n* age 18-75 years\n* patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index \\[RSI\\] ≥ 13 or Reflux Symptom Score-12 \\[RSS-12\\] ≥ 11) signed informed consent\n\nExclusion Criteria:\n\n* patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway\n* severe neurological disease affecting swallowing\n* pregnancy\n* surgery involving the head, neck, or esophagus within the last 6 months","75 Years",{"count":50,"type":22},160,[52],"NA","The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.",[55,28,56,57],"Extraesophageal Reflux","Dysphagia","Chronic Cough",[59,60,56,61,62,63],"Extraesophageal reflux","Laryngopharyngeal reflux","Chronic cough","high-resolution manometry","24-hour pH-impedance monitoring","2026-01-15",{"date":66,"type":33},"2026-01-23",{"date":68,"type":22},"2026-01",{"date":70,"type":22},"2028-12",{"name":72,"class":40},"University Hospital Ostrava",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":41},"100592910","phase-4-the-mechanism-versus-ppi-trial-100592910","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","89 Years",{"count":50,"type":22},[84],"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",[28,87,88,89,90],"Cough","Throat Clearing","Dysphonia","Reflux","RECRUITING","2025-07-29",{"date":94,"type":33},"2025-08-01",{"date":96,"type":33},"2025-06-04",{"date":98,"type":22},"2029-07-01",{"name":100,"class":40},"University of California, San Diego"]