A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 m… (NCT06953986) | Clinical Trial Compass
RecruitingNot Applicable
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
India414 participantsStarted 2025-12-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
Timeframe: 8 weeks
2
Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).