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.
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
- Vonaprazan 10 mg once daily
- Vonaprazan 20 mg once daily
- 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.
Eligibility
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.