Clinical trial NCT06955520: Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Official title: Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GERD
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: • Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).
timeFrame: 8 weeks
Secondary outcomes:
measure: • Improvement in GERD-Q scores at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Dr Ramchandani, MD DM
role: STUDY_DIRECTOR
References: