Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India, 500082
Actively Recruiting
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
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