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The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days | Active Comparator | 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
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| Vonoprazan+amoxicillin+clarithromycin 14 days | Experimental | 14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
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| Vonoprazan+amoxicillin+clarithromycin 7 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
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| Vonoprazan+tetracycline+furazolidone 14 days | Experimental | 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
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| Vonoprazan+tetracycline+furazolidone 7 days | Experimental | 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazloe+bismuth+amoxicillin+clarithromycin | Drug | PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori | Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure). | Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse effects | According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ying han | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Vonoprazan+amoxicillin+furazolidone 7 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid. |
|
| Vonoprazan+amoxicillin+tetracycline 14 days | Experimental | 7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid. |
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| Vonoprazan+amoxicillin 7 days | Experimental | 7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. |
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| Vonoprazan+amoxicillin 14 days | Experimental | 14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid. |
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| Vonoprazan+amoxicillin+clarithromycin 14 days | Drug | VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
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| Vonoprazan+amoxicillin+clarithromycin 7 days | Drug | VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid. |
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| Vonoprazan+tetracycline+furazolidone 14 days | Drug | VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
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| Vonoprazan+tetracycline+furazolidone 7 days | Drug | VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid. |
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| Vonoprazan+amoxicillin+furazolidone 7 days | Drug | hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid. |
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| Vonoprazan+amoxicillin+tetracycline 14 days | Drug | hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid. |
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| Vonoprazan+amoxicillin 7 days | Drug | hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid. |
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| Vonoprazan+amoxicillin 14 days | Drug | hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid. |
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| 14 days of treatment, and 28 days after treatment |
| Treatment compliance | Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence; | 7 or 14 days of treatment |
| Symptom relief rate | Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms. | 14 days of treatment, and 28 days after treatment |