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| Name | Class |
|---|---|
| Longkou People's Hospital | UNKNOWN |
| Qingdao Jimo People's Hospital | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
| Dezhou Hospital Qilu Hospital of Shandong University |
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This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy | Experimental |
| |
| 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy | Active Comparator |
| |
| 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy | Drug | vonoprazan 20mg bid + amoxicillin 1000mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| eradication rate | 6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | immediately after a 2-week treatment | |
| compliance | Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyue Li | Contact | +8618560089751 | lyynqj@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| OTHER |
| Zibo Maternal and Child Health Hospital | OTHER |
| Guanxian County People's Hospital | OTHER |
| Yantai Zhifu Hospital | OTHER |
| Dongying No. 2 People's Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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| 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy | Drug | vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid |
|
| 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy | Drug | vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid |
|
| immediately after a 2-week treatment |
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | China |
|