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

ConditionGERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vonoprazan
  • Esomeprazole 40mg

Treatment groups

300 Participants
are divided into 2 treatment groups