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This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.
Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.
This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.
Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days | Experimental | Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days |
|
| Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days | Experimental | Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days |
|
| Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days | Active Comparator | Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Potassium-competitive acid blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori Eradication Rate | Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. | Six to eight weeks after completion of the medication |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Drug Reaction(ADR) | Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). | Within 7 days after completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Du, Master | Contact | +86 0571-89713734 | duq518@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36458325 | Derived | Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1. |
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| Esomeprazole | Drug | Proton pump inhibitor |
|
| Colloidal bismuth pectin | Drug | Gastric mucosal protective drug with anti-H. pylori effect |
|
| Amoxicillin | Drug | Antibiotic for H. pylori eradication |
|
| Furazolidone | Drug | Antibiotic for H. pylori eradication |
|
| Compliance Rate |
Compliance was defined as poor when they had taken less than 80% of the total medication. |
| Within 7 days after completion of therapy |
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D005664 | Furazolidone |
| 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 |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D005663 | Furans |
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