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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-07

Study Completion Date

2027-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks

Vonaprazon 10 mg heals gerd symptoms after 8 weeks

Group Type OTHER

Vonoprazan

Intervention Type DRUG

Vonaprazon is potassium competitive acid blockers

To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks

Vonaprazon 20 mg heals gerd symptoms after 8 weeks

Group Type OTHER

Vonoprazan

Intervention Type DRUG

Vonaprazon is potassium competitive acid blockers

To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks

Esomeprazole 40mg heals gerd symptoms after 8 weeks

Group Type OTHER

Esomeprazole 40mg

Intervention Type DRUG

esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Interventions

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Vonoprazan

Vonaprazon is potassium competitive acid blockers

Intervention Type DRUG

Esomeprazole 40mg

esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Intervention Type DRUG

Other Intervention Names

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PCAB Proton pump inhibitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No