Comparing two doses of vonoprazan and esomeprazole for healing moderate-to-severe reflux esophagitis in 8 weeks
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 414 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06953986 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 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.