NCT06953986

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily. Secondary Objectives * To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events across treatment groups.

Detailed description

Study Design: * This is a randomized, open-label, parallel-group, non-inferiority trial. Randomization and Blinding * Participants will be randomized in a 1:1:1 ratio to receive Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks. * Randomization will be stratified by baseline severity of esophagitis (LA grade B vs. C/D). * The study will be open-label, but the outcome assessors will be blinded. Study Arms 1. Vonaprazan 10 mg once daily 2. Vonaprazan 20 mg once daily 3. Esomeprazole 40 mg once daily Duration: * 8 weeks of treatment, followed by endoscopic assessment and symptom evaluation. I Study Procedures: Baseline : * Perform upper GI endoscopy to confirm LA grade B or higher esophagitis. * Record baseline GERD-Q score. * Randomize participants into one of the three treatment groups. * Dispense study medication. Follow-up (Week 4 - Interim Assessment) * Assess GERD-Q score. * Monitor adherence and adverse events. End-of-Treatment (Week 8 - Primary Outcome Assessment) * Repeat upper GI endoscopy to assess mucosal healing. * Reassess GERD-Q score. * Collect adverse event data. * Conclude study participation.

Conditions

• GERD

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonaprazon is potassium competitive acid blockers
DRUG	Esomeprazole 40mg	esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-11-20
• Completion: 2027-12-12
• First posted: 2025-05-01
• Last updated: 2026-03-06

Locations

1 site across 1 country: India