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

March 4, 2026 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design:

  • This is a randomized, open-label, parallel-group, non-inferiority trial. Randomization and Blinding
  • Participants will be randomized in a 1:1:1 ratio to receive Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks.
  • Randomization will be stratified by baseline severity of esophagitis (LA grade B vs. C/D).

  • The study will be open-label, but the outcome assessors will be blinded. Study Arms

    1. Vonaprazan 10 mg once daily
    2. Vonaprazan 20 mg once daily

    3. Esomeprazole 40 mg once daily

      Duration:

  • 8 weeks of treatment, followed by endoscopic assessment and symptom evaluation.

I

Study Procedures:

Baseline :

  • Perform upper GI endoscopy to confirm LA grade B or higher esophagitis.
  • Record baseline GERD-Q score.
  • Randomize participants into one of the three treatment groups.
  • Dispense study medication. Follow-up (Week 4 - Interim Assessment)
  • Assess GERD-Q score.
  • Monitor adherence and adverse events. End-of-Treatment (Week 8 - Primary Outcome Assessment)
  • Repeat upper GI endoscopy to assess mucosal healing.
  • Reassess GERD-Q score.
  • Collect adverse event data.
  • Conclude study participation.

Study Type

Interventional

Enrollment (Estimated)

414

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian Institute of Gastroenterology /Aig Hospitals
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks
Vonaprazon 10 mg heals gerd symptoms after 8 weeks
Drug: Vonoprazan
Vonaprazon is potassium competitive acid blockers
Other Names:
  • PCAB
Other: To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks
Vonaprazon 20 mg heals gerd symptoms after 8 weeks
Drug: Vonoprazan
Vonaprazon is potassium competitive acid blockers
Other Names:
  • PCAB
Other: To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks
Esomeprazole 40mg heals gerd symptoms after 8 weeks
Drug: Esomeprazole 40mg
esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
Other Names:
  • Proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
Time Frame: 8 weeks
healing of ulcers after taking vonaprazon 10mg, 20 mg
8 weeks
Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
Time Frame: 8 weeks
healing of ulcers after taking esomeprazole 40mg
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• GERD-Q score improvement at 8 weeks (compared to baseline).
Time Frame: 8 weeks
symtoms improvement like heartburn, regurgitation which can be calculated with scale 1 (mild symptoms ) to 5 (worse symptoms)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Study Director: Mohan Dr Ramchandani, MD DM, Asian Institute Of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 12, 2027

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNP2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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