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

NCT06955520 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Not applicable

Started

2025-04-30

Last updated

2026-04-27

Condition(s) studied

GERD

Investigational drug(s) / intervention(s)

Vonoprazan →Esomeprazole 40mg →

Vonoprazan: a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.

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)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years * History of POEM for achalasia * Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM * GERD symptoms (heartburn, regurgitation) for ≥4 weeks * Willingness to provide informed consent and comply with study procedures Exclusion Criteria: * History of prior anti-reflux surgery * Presence of Barrett's esophagus, esophageal stricture, or malignancy * Severe gastroparesis or esophageal motility disorder unrelated to achalasia * Pregnancy or breastfeeding * Severe hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min) * Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal healing

Primary outcome measure(s)

• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis). — 8 weeks
This can be find during endoscopy test

Trial sites (1)

Facility	City	Region	Status
Asian Institute of Gastroenterology /Aig Hospitals	Hyderabad	Telangana	Recruiting

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Other trials for the same condition

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 Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06955520 on ClinicalTrials.gov ↗ ← All trials in India