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

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: GERD

Treatments: Drug: Vonoprazan; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06953986

VNP2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 414 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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414 participants in 3 patient groups

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

Other group

Description:

Vonaprazon 10 mg heals gerd symptoms after 8 weeks

Treatment:

Drug: Vonoprazan

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

Other group

Description:

Vonaprazon 20 mg heals gerd symptoms after 8 weeks

Treatment:

Drug: Vonoprazan

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

Other group

Description:

Esomeprazole 40mg heals gerd symptoms after 8 weeks

Treatment:

Drug: Esomeprazole 40mg