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

Launched by ASIAN INSTITUTE OF GASTROENTEROLOGY, INDIA · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective three different medications are at helping heal a condition called reflux esophagitis, which is often caused by gastroesophageal reflux disease (GERD). The medications being tested are Vonaprazan at two different doses (10 mg and 20 mg) and Esomeprazole (40 mg). The main goal is to see which treatment helps heal this condition the best over an 8-week period. Additionally, the trial will look at how each treatment affects symptoms like heartburn and regurgitation, as well as any side effects that patients may experience.

To participate in this study, you need to be an adult aged 18 or older with a confirmed diagnosis of reflux esophagitis (specifically LA grade B, C, or D) and have been experiencing GERD symptoms for at least four weeks. However, if you've had certain treatments in the last month, prior surgeries, specific medical conditions, or are pregnant or breastfeeding, you may not be eligible. If you decide to join, you can expect to take one of the medications once daily for eight weeks and attend follow-up appointments to monitor your progress. This could be a valuable opportunity to help find better treatments for reflux esophagitis.

Gender

ALL

Eligibility 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.