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Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-KA-dual-14 | Active Comparator | 14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral) |
|
| L-KA-dual-14 | Experimental | 14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral) |
|
| H-KA-dual-10 | Experimental | 10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keverprazan Hydrochloride tablets + high dose amoxicillin | Drug | Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day |
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure. | 6 weeks |
| Medical financial burden | Medical financial burden;Questionnaire that will be used to assess this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Honglei Chen, MD | Contact | 18138728623 | chenhlei3@mail.sysu.edu.cn | |
| Shanshan Wei, MD | Contact | 18823305248 | weishsh7@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shanshan Wei, MD | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Huizhen Xiong | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
The datasets used and analysed during the current study available from the corresponding author on reasonable request.
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|
| Keverprazan Hydrochloride tablets + low dose amoxicillin | Drug | Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day |
|
|
| Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d) | Drug | Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day |
|
|
| 6 weeks |
| Meifang Ye |
| The Eighth Affiliated Hospital,sun Yet-san University |
| Study Chair |
| Jianfeng Zhong | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Wei Liu | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Fang Liu | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Ting Zhou | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Qiucheng Li | The Eighth Affiliated Hospital,sun Yet-san University | Study Chair |
| Puning Overseas Chinese Hospital | Recruiting | Puning | Guangdong | 515300 | China |
|
| Eighth Affiliated Hospital,Sun Yet-san University | Recruiting | Shenzhen | Guangdong | 518033 | China |
|
| Xiangyang Hospital of Traditional Chinese Medicine | Recruiting | Xiangyang | Hubei | 441000 | China |
|
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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