Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM (NCT06955520) | Clinical Trial Compass
RecruitingNot Applicable
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
India300 participantsStarted 2025-04-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).