Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06955520

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

Led by Asian Institute of Gastroenterology, India · Updated on 2026-04-27

300

Participants Needed

1

Research Sites

190 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • History of Peroral Endoscopic Myotomy (POEM) for achalasia
  • Endoscopic confirmation of Los Angeles grade B, C, or D reflux esophagitis at 3 months post-POEM
  • Experiencing GERD symptoms such as heartburn or regurgitation for 4 weeks or more
  • Willing to provide informed consent and follow study procedures
Not Eligible

You will not qualify if you...

  • History of prior anti-reflux surgery
  • Presence of Barrett's esophagus, esophageal stricture, or esophageal cancer
  • Severe gastroparesis or esophageal motility disorders not related to achalasia
  • Pregnancy or breastfeeding
  • Severe liver or kidney problems (ALT/AST over 3 times normal limit, eGFR less than 30 mL/min)
  • Regular use of NSAIDs, steroids, or blood thinners that may affect esophageal healing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, India, 500082

Actively Recruiting

Loading map...

Research Team

R

Rajesh Goud Mr Maragoni, M.Pharm

CONTACT

Z

Zaheer Nabi Dr Mohammed, MD DNB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here