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

Official title

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

Overview

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.

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.

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

Primary outcome measures

• • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). [Time frame: 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]

Secondary outcome measures (1)

• • GERD-Q score improvement at 8 weeks (compared to baseline). [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Treatment

Study locations

India · 1 center

• Asian Institute of Gastroenterology /Aig Hospitals — Hyderabad

Identifiers

NCT: NCT06953986 · VNP2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗