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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
Study Type:
• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial
Randomization and Blinding:
Study Timeline:
Study Arms:
Study Procedures:
Baseline Assessment (3 Months Post-POEM, Before Randomization)
End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug | Active Comparator | healing rate will be checked during endoscopy at 8 weeks |
|
| To see the healing rate of grade B esophagitis | Placebo Comparator | healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis). | This can be find during endoscopy test | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • Improvement in GERD-Q scores at 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) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Goud Mr Maragoni, M.Pharm | Contact | 04023378888 | 312 | rajeshgoud761@gmail.com |
| Zaheer Nabi Dr Mohammed, MD DNB | Contact | 04023378888 | 427 | zaheernabi1978@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohan Dr Ramchandani, MD DM | Asian Institute of Gastroenterology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology /Aig Hospitals | Recruiting | Hyderabad | Telangana | 500082 | India |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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Outcome assessor will be blinded for this study
|
| Esomeprazole 40mg | Drug | 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) |
|
|
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |