Sucralfate/sodium alginate capsules and PPI-refractory reflux symptoms in non-erosive reflux disease and mild erosive disease: a randomized, phase 3, non-inferiority study.

PURPOSE: Proton pump inhibitors have failed to control symptoms in some patients with gastroesophageal reflux disease. We investigated the effect of alginate and sucralfate capsules (ALSUC) in patients who had not responded to proton pump inhibitors. PATIENTS AND METHODS: From March 2024 to March 2025, 692 adult patients with mild esophagitis (Los Angeles classification grades A, B) and NERD with reflux symptoms ≥4 days/week were randomly assigned to receive ALSUC after meals and at bedtime or a double dose of omeprazole (20 mg) twice daily for 8 weeks. Patients were asked to complete a daily questionnaire. The primary endpoint was the percentage of complete heartburn-free days, analyzed for non-inferiority. The secondary endpoints were analyzed for superiority. RESULTS: ALSUC was noninferior to omeprazole in terms of percentage of heartburn-free days (omeprazole: 50.9%, ALSUC: 49.1%, CI: -0.003, 0.039). The percentage of regurgitation-free days was significantly higher in the ALSUC group (omeprazole: 49.8%, ALSUC: 53.5%, CI: -0.059, -0.016, p= 0.001). In the subgroup analysis, no significant differences were observed between the two groups within either the NERD or esophagitis subgroups for the evaluated outcomes. The exceptions were that omeprazole offered better heartburn control in patients with esophagitis, whereas ALSUC provided better control of regurgitation in patients with NERD. CONCLUSION: ALSUC can be a safe approach in controlling symptoms of mild esophagitis and NERD.