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This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| groupA: dual therapy (vonoprazan+amoxicillin) | Experimental | vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days |
|
| group B: dual therapy (rabeprazole+amoxicillin) | Experimental | rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days |
|
| group C: bismuth-containing quadruple therapy | Active Comparator | rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days |
|
| 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. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. | 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 |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064750 | Rabeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole |
| Drug |
Proton pump inhibitor |
|
| Amoxicillin | Drug | Antibiotic for H. pylori eradication |
|
| Clarithromycin | Drug | Antibiotic for H. pylori eradication |
|
| Colloidal bismuth pectin | Drug | Gastric mucosal protective drug with anti-H. pylori effect |
|
| 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 |
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |