Vonaprazan versus Esomeprazole for healing moderate-to-severe reflux esophagitis after POEM
Official title: Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Run by Asian Institute of Gastroenterology, India · NCT06955520 · Data updated 2026-11-12
This trial tests whether vonaprazan or esomeprazole better heals LA grade B or higher reflux esophagitis in adults who developed it after POEM.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | December 10, 2027 |
| Study ends | December 25, 2028 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT06955520 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who had POEM for achalasia and now have endoscopic LA grade B or higher reflux esophagitis with reflux symptoms at three months post-POEM are the intended participants.
✕Probably not a fit
Patients with prior anti-reflux surgery, Barrett's esophagus, esophageal stricture or malignancy, severe organ impairment, pregnancy or breastfeeding, or who use medications that impair healing are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients who have undergone POEM and show LA grade B or higher esophagitis at three months are randomized 1:1 to vonaprazan 20 mg once daily or esomeprazole 40 mg once daily for eight weeks. Before randomization all participants receive a two-month course of esomeprazole followed by a one-month PPI washout to allow persistent reflux esophagitis to manifest. The trial is open-label but uses blinded outcome assessors and stratifies randomization by baseline LA grade (B versus C/D). The primary endpoint is endoscopic healing of esophagitis at eight weeks post-randomization, with symptom scores (GERD-Q) and adverse events as secondary outcomes.
Why it matters
Potential benefit: If successful, the trial could identify a treatment that heals post-POEM reflux esophagitis more reliably, reducing symptoms and the risk of complications.
How similar studies have gone: Previous studies have shown vonaprazan provides stronger acid suppression and similar or better healing than PPIs in erosive esophagitis generally, but its specific use for post-POEM reflux esophagitis has been less studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India Recruiting
Study contacts
- Study coordinator: Rajesh Goud Mr Maragoni, M.Pharm
- Email: rajeshgoud761@gmail.com
- Phone: 04023378888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.