Status:
RECRUITING
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
GERD
Eligibility:
All Genders
18-75 years
Phase:
NA
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 grad...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06955520
Start Date
April 30 2025
End Date
December 25 2028
Last Update
June 12 2025
Active Locations (1)
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1
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India, 500082