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

Last updated: June 9, 2025
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

Esomeprazole 40mg

Vonoprazan

Clinical Study ID

NCT06955520
PFCNet 1
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • History of POEM for achalasia

  • Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 monthspost-POEM

  • GERD symptoms (heartburn, regurgitation) for ≥4 weeks

  • Willingness to provide informed consent and comply with study procedures

Exclusion

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

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Esomeprazole 40mg
Phase:
Study Start date:
April 30, 2025
Estimated Completion Date:
December 25, 2028

Study 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.

Connect with a study center

  • Asian Institute of Gastroenterology /Aig Hospitals

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

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