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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Vonoprazan

    Drug

    a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.

  • Esomeprazole 40mg

    Drug

    It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\>5mm ulcer between two mucosal folds in esophagus)

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: To assess the efficacy of vonapraprazon 20mg better than esomeprazole drugActive comparator 1 intervention
Group B: To see the healing rate of grade B esophagitisPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).

This can be find during endoscopy test

Time frame
8 weeks

Secondary outcomes

1

• Improvement in GERD-Q scores at 8 weeks

GERD questionnaire can be calculated based on heart burn , regurgitation symptom scores which is scaled like 1 is very low symptoms, 5 is worse symptoms (outcome)

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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