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
NCT06953986 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 414
Last updated 2026-03-06
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.
Conditions
- GERD
Interventions
- DRUG
-
Vonoprazan
Vonaprazon is potassium competitive acid blockers
- DRUG
-
Esomeprazole 40mg
esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
Sponsors & Collaborators
-
Asian Institute of Gastroenterology, India
lead OTHER
Principal Investigators
-
Mohan Dr Ramchandani, MD DM · Asian Institute of Gastroenterology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-20
- Primary Completion
- 2026-11-20
- Completion
- 2027-12-12
Countries
- India
Study Locations
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