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Primary Objective
• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily.
Secondary Objectives
Study Design:
This is a randomized, open-label, parallel-group, non-inferiority trial. Randomization and Blinding
Participants will be randomized in a 1:1:1 ratio to receive Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks.
Randomization will be stratified by baseline severity of esophagitis (LA grade B vs. C/D).
The study will be open-label, but the outcome assessors will be blinded. Study Arms
Vonaprazan 10 mg once daily
Vonaprazan 20 mg once daily
Esomeprazole 40 mg once daily
Duration:
8 weeks of treatment, followed by endoscopic assessment and symptom evaluation.
I
Study Procedures:
Baseline :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks | Other | Vonaprazon 10 mg heals gerd symptoms after 8 weeks |
|
| To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks | Other | Vonaprazon 20 mg heals gerd symptoms after 8 weeks |
|
| To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks | Other | Esomeprazole 40mg heals gerd symptoms after 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonaprazon is potassium competitive acid blockers |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). | healing of ulcers after taking vonaprazon 10mg, 20 mg | 8 weeks |
| Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). | healing of ulcers after taking esomeprazole 40mg | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • GERD-Q score improvement at 8 weeks (compared to baseline). | symtoms improvement like heartburn, regurgitation which can be calculated with scale 1 (mild symptoms ) to 5 (worse symptoms) | 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 | 410 | rajeshgoud761@gmail.com |
| Zaheer Dr Nabi, MD DNB | Contact | 04023378888 | 503 | 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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|
| Esomeprazole 40mg | Drug | esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach |
|
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064098 | Esomeprazole |
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| 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 |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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