A Randomized, Three-Arm 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
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
Asian Institute of Gastroenterology, India
414 participants
Dec 20, 2025
INTERVENTIONAL
Conditions
Summary
Primary Objective • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily. Secondary Objectives * To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events across treatment groups.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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.
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Interventions
Vonaprazon is potassium competitive acid blockers
esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
Locations(1)
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NCT06953986