Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: GERD

Treatments: Drug: Vonoprazan; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06955520

PFCNet 1

Details and patient eligibility

About

Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.

Primary Objective:

• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg.

Secondary Objectives

• To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.
• To evaluate the incidence of adverse events in each treatment group.

Full description

Study Type:

• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial

Randomization and Blinding:

• Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.
• Stratification: Based on LA grade (B vs. C/D) at baseline.
• Blinding: Open-label study, but outcome assessors will be blinded.

Study Timeline:

1. All post-POEM patients receive Esomeprazole 40 mg for 2 months.
2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).
3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.
4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.

Study Arms:

• Arm A: Vonaprazan 20 mg once daily for 8 weeks
• Arm B: Esomeprazole 40 mg once daily for 8 weeks

Study Procedures:

Baseline Assessment (3 Months Post-POEM, Before Randomization)

• Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.
• GERD-Q Score assessment.
• Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)
• GERD-Q Score assessment.

End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)

• Upper GI Endoscopy to assess healing of reflux esophagitis.
• GERD-Q Score reassessment.
• Final adverse event reporting.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• History of POEM for achalasia
• Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM
• GERD symptoms (heartburn, regurgitation) for ≥4 weeks
• Willingness to provide informed consent and comply with study procedures

Exclusion criteria

• History of prior anti-reflux surgery
• Presence of Barrett's esophagus, esophageal stricture, or malignancy
• Severe gastroparesis or esophageal motility disorder unrelated to achalasia
• Pregnancy or breastfeeding
• Severe hepatic or renal impairment (ALT/AST >3× ULN, eGFR <30 mL/min)
• Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal healing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups, including a placebo group

To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug

Active Comparator group

Description:

healing rate will be checked during endoscopy at 8 weeks

Treatment:

Drug: Vonoprazan

To see the healing rate of grade B esophagitis

Placebo Comparator group

Description:

healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg

Treatment:

Drug: Esomeprazole 40mg