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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

RecruitingNAAges 18 Years - 75 YearsAllAsian Institute of Gastroenterology, India
NCT06953986 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vonoprazan
  • Esomeprazole 40mg
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Where

1 site
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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