drugset / Trial / NCT06955520

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

NCT06955520

RandomizedParallel-groupSingle-blindTreatment

Summary

Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. Primary Objective: • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg. Secondary Objectives * To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events in each treatment group.

Timeline

Start
2025-04-30
Primary completion
2027-12-10
Completion
2028-12-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg
Comparator Vonoprazan Other / unclassified 20 mg