GERD
Conditions
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.
Interventions
DRUGVonoprazan
a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
DRUGEsomeprazole 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)
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded for this study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • 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
| Measure | Time frame | Description |
|---|---|---|
| • 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) |
Countries
India
Contacts
CONTACTRajesh Goud Mr Maragoni, M.Pharm
CONTACTZaheer Nabi Dr Mohammed, MD DNB
STUDY_DIRECTORMohan Dr Ramchandani, MD DM
Asian Institute of Gastroenterology
Outcome results
None listed