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To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) | Active Comparator | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days |
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| Vonoprazan Fumarate+Amoxycillin 14days (VA14) | Experimental | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days |
|
| Vonoprazan Fumarate+Amoxycillin 7days (VA7) | Experimental | Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days |
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| Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) | Experimental | Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days |
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| Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) | Experimental | Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) | Drug | VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter Pylori eradication rate | The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms effective rates | symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaqiang Dong | Contact | 86-029-84771506 | dongjiaqiang1988@163.com | |
| Yongquan Shi | Contact | 86-029-84771515 | shiyquan@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ying Han | Xijing Hosipital of Digestive Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Vonoprazan Fumarate+Amoxycillin 14days (VA14) | Drug | VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days |
|
| Vonoprazan Fumarate+Amoxycillin 7days (VA7) | Drug | VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days |
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| Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) | Drug | VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days |
|
| Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) | Drug | VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days |
|
| 14 days of treatment, and 28 days after treatment |
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain. | 14 days of treatment, and 28 days after treatment |