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
Vonoprazan: Vonaprazon is potassium competitive acid blockers
Esomeprazole 40mg: esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). — 8 weeks healing of ulcers after taking vonaprazon 10mg, 20 mg
Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). — 8 weeks healing of ulcers after taking esomeprazole 40mg
Trial sites (1)
Facility
City
Region
Status
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad
Telangana
Recruiting
More Asian Institute of Gastroenterology, India trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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