Vonaprazan versus Esomeprazole for healing moderate-to-severe reflux esophagitis after POEM
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06955520 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hyderabad, Telangana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.