drugset / Trial / NCT07611162

Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease

NCT07611162

Phase 4 Not yet recruiting 800 enrolled University of Mons
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this randomized controlled trial is to compare the effectiveness of different treatments for laryngopharyngeal reflux disease (LPRD) in adult patients with confirmed symptoms and signs of the condition. The main question it aims to answer is: Which treatment (Proton Pump Inhibitors (PPIs), alginate, magaldrate, sucralfate, or diet) leads to the greatest improvement in LPRD symptoms and clinical signs over 3 months? Researchers will compare proton pump inhibitors to alternative medical treatments and dietary management to see which approach is most effective and better tolerated. Participants will: * undergo a clinical ENT examination with scoring of reflux signs (RSA) * complete symptom questionnaires (RSS) assessing severity, frequency, and impact of symptoms * receive one of the study treatments (medication or dietary intervention) * be evaluated at baseline and again after 3 months of treatment

Timeline

Start
2026-05-01
Primary completion
2030-05-01
Completion
2030-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alginic acid Other / unclassified
Subject Esomeprazole Small molecule
Subject Lansoprazole Other / unclassified
Comparator MAGALDRATE ANHYDROUS Small molecule
Subject Omeprazole Other / unclassified
Subject Pantoprazole Other / unclassified
Subject Rabeprazole Small molecule
Comparator Sucralfate Unknown