Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
NCT ID: NCT06955520
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-04-30
2028-12-25
Brief Summary
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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.
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Detailed Description
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• 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug
healing rate will be checked during endoscopy at 8 weeks
Vonoprazan
a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
To see the healing rate of grade B esophagitis
healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg
Esomeprazole 40mg
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)
Interventions
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Vonoprazan
a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
Esomeprazole 40mg
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Director
Principal Investigators
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Mohan Dr Ramchandani, MD DM
Role: STUDY_DIRECTOR
Asian Institute of Gastroenterology
Locations
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Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PFCNet 1
Identifier Type: -
Identifier Source: org_study_id
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