NCT06955520

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Type: • Randomized, Open-Label, Two-Arm, Non-Inferiority Trial Randomization and Blinding: * Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg. * Stratification: Based on LA grade (B vs. C/D) at baseline. * Blinding: Open-label study, but outcome assessors will be blinded. Study Timeline: 1. All post-POEM patients receive Esomeprazole 40 mg for 2 months. 2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists). 3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks. 4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed. Study Arms: * Arm A: Vonaprazan 20 mg once daily for 8 weeks * Arm B: Esomeprazole 40 mg once daily for 8 weeks Study Procedures: Baseline Assessment (3 Months Post-POEM, Before Randomization) * Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis. * GERD-Q Score assessment. * Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit) * GERD-Q Score assessment. End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM) * Upper GI Endoscopy to assess healing of reflux esophagitis. * GERD-Q Score reassessment. * Final adverse event reporting.

Conditions

• GERD

Interventions

Type	Name	Description
DRUG	Vonoprazan	a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
DRUG	Esomeprazole 40mg	It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\>5mm ulcer between two mucosal folds in esophagus)

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-12-10
• Completion: 2028-12-25
• First posted: 2025-05-02
• Last updated: 2025-06-12

Locations

1 site across 1 country: India