Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
- Registration Number
- NCT06955520
- Lead Sponsor
- Asian Institute of Gastroenterology, India
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug Vonoprazan healing rate will be checked during endoscopy at 8 weeks To see the healing rate of grade B esophagitis Esomeprazole 40mg healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg
- Primary Outcome Measures
Name Time Method • Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis). 8 weeks This can be find during endoscopy test
- Secondary Outcome Measures
Name Time Method • Improvement in GERD-Q scores at 8 weeks 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)