NCT06955520 Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
| NCT ID | NCT06955520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | GERD |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-04-30 with a primary completion date of 2027-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Mohan Dr Ramchandani, MD DM
STUDY DIRECTOR
Asian Institute of Gastroenterology, India
Frequently Asked Questions
Who can join the NCT06955520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying GERD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06955520 currently recruiting?
Yes, NCT06955520 is actively recruiting participants. Contact the research team at rajeshgoud761@gmail.com for enrollment information.
Where is the NCT06955520 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT06955520 clinical trial?
NCT06955520 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Mohan Dr Ramchandani, MD DM at Asian Institute of Gastroenterology, India. The trial plans to enroll 300 participants.