Comparing two doses of vonoprazan and esomeprazole for healing moderate-to-severe reflux esophagitis in 8 weeks
Official title: Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks
Run by Asian Institute of Gastroenterology, India · NCT06953986 · Data updated 2026-11-12
This study will test whether taking vonoprazan (10 mg or 20 mg) or esomeprazole 40 mg once daily heals moderate-to-severe reflux esophagitis after 8 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 414 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | November 20, 2026 |
| Study ends | December 12, 2027 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT06953986 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with endoscopically confirmed LA grade B, C, or D reflux esophagitis and at least 4 weeks of GERD symptoms who can provide consent and attend the Hyderabad study site are ideal candidates.
✕Probably not a fit
Patients with Barrett's esophagus, esophageal stricture or malignancy, prior esophageal surgery or radiation, PPI-refractory disease, significant liver or kidney impairment, pregnancy or breastfeeding, or current use of NSAIDs/steroids/anticoagulants are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with endoscopically confirmed LA grade B, C, or D reflux esophagitis are randomized 1:1:1 to vonoprazan 10 mg, vonoprazan 20 mg, or esomeprazole 40 mg once daily for 8 weeks in an open-label, parallel-group, non-inferiority design with blinded outcome assessment. Randomization is stratified by baseline esophagitis severity (LA B vs C/D). The primary endpoint is endoscopic mucosal healing at 8 weeks, with secondary endpoints including change in GERD-Q symptom score and incidence of adverse events. Key procedures include baseline and week-8 endoscopy, interim symptom check at week 4, and safety monitoring throughout treatment.
Why it matters
Potential benefit: If successful, vonoprazan could offer equal or better healing and symptom relief within 8 weeks compared with standard esomeprazole, providing an alternative acid suppression option.
How similar studies have gone: Prior studies of vonoprazan and other potassium-competitive acid blockers have shown equal or faster acid suppression and comparable or superior healing to proton pump inhibitors, so this approach builds on emerging positive evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years of age. * Endoscopically confirmed LA grade B, C, or D reflux esophagitis. * GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment. * Willing to provide informed consent and comply with study procedures. Exclusion Criteria: * Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks. * Prior esophageal surgery or radiation therapy. * Barrett's esophagus, esophageal stricture, or malignancy. * Pregnant or breastfeeding women. * History of PPI-refractory GERD or severe gastroparesis. * Significant hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min). * Use of NSAIDs, steroids, or anticoagulants affecting 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.